FDA Adverse Event Injury Summary report: N

PEDIATRIC LCP(TM) HIP PLATE 3.5MM 120°

MDR report key: 5087873 · Received September 18, 2015

Report

Report Number: 2520274-2015-15989
Event Type: Injury
Date Received: September 18, 2015
Report Date: September 7, 2015
Manufacturer: SYNTHES RARON
Product Code: HRS
PMA / PMN Number: PK112085
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). THIS REPORT IS FOR AN UNKNOWN PÄDI HIP PLATE 3,5 MM SYSTEM, 120°, 4-HOLE/UNKNOWN LOT. UNKNOWN IF DEVICE HAS BEEN EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 02.108.313 LOT. 9083635, MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 06. AUG. 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON RECEIPT OF SUBJECT DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

THE EXACT DATE OF SYMPTOM ONSET IS UNKNOWN; HOWEVER, IT WAS REPORTED TO THE PHYSICIAN IN EARLY AUGUST, 2015. (B)(6). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

THE COMPLAINED PARTS WERE NOT RETURNED TO THE MANUFACTURER; HOWEVER AN EXTERNAL MATERIAL ANALYTIC COMPANY REPORT WAS RECEIVED WHICH WAS REVIEWED AND SUMMARIZED BY THE MANUFACTURE. INFORMATION FROM MANUFACTURER REVIEW: THE COMPLAINT IS CONFIRMED AS POST-OPERATIVE BREAKAGE IS VISIBLE ON THE RECEIVED PICTURES: SCREW (PART 213.050, LOT 9093559, QUANTITY 2) AND SCREW (PART 213.040, LOT 9011497, QUANTITY 1). THERE WAS NO REPORTED PRODUCT PROBLEM RELATING TO THE PLATE (PART 02.108.313, LOT¿ 9083635, QUANTITY 1) OR CONCOMITANT DEVICES. THE MANUFACTURING DOCUMENTS OF THE ABOVE MENTIONED PARTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. BASED ON THE PROVIDED INFORMATION AND WITHOUT MATERIAL IS NO FURTHER EVALUATION POSSIBLE. SUMMARY OF EXTERNAL ANALYSIS: THE MATERIAL OF THE SCREWS WAS ANALYZED AND FOUND TO CORRESPOND TO STAINLESS STEEL (1.1441). NO PRODUCT FAULT COULD BE DETECTED. IT WAS CONCLUDED THAT LIKELY AN OVERLOADING SITUATION OCCURRED RESULTING IN THE BREAKAGE OF THE THREE (3) SCREWS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

UNKNOWN, IT WAS REPORTED THAT THE PAIN AND DIFFICULTY WALKING STARTED ON (B)(6) 2015. IT IS UNKNOWN WHEN THE PLATE MIGRATED AND THE SCREWS BROKE. ADDITIONAL PRODUCT CODE: HWC. (B)(4). PHONE NUMBER: (B)(6). (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.