FDA Adverse Event Injury Summary report: N

3.5MM CORTEX SCREW SELF-TAPPING 16MM

MDR report key: 5348512 · Received January 6, 2016

Report

Report Number: 2520274-2016-10069
Event Type: Injury
Date Received: January 6, 2016
Report Date: December 17, 2015
Manufacturer: SYNTHES USA
Product Code: HWC
PMA / PMN Number: PPREAMEND
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL 510K CODE: K131186. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A NONUNION OF THE PATIENT'S RIGHT CLAVICLE. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2015 DUE TO AN UNSPECIFIED EVENT THAT CREATED THE NONUNION OF THE PATIENT'S RIGHT CLAVICLE. UPON THE COMPLETION OF THE INITIAL SURGERY IT WAS DETERMINED BY UNSPECIFIED MEASURES THAT THE INITIAL CONSOLE DID NOT HOLD THE BONE INTACT. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE ORIGINAL CONSOLE TO CORRECT THE NONUNION. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAYS IN SURGERY OR ILL-AFFECTS SUFFERED BY THE PATIENT. X-RAYS WILL NOT BE MADE AVAILABLE. THIS COMPLAINT INVOLVES EIGHT PARTS. THIS REPORT IS 5 OF 8 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
7283	3.5MM CORTEX SCREW SELF-TAPPING 16MM	SCREW, FIXATION, BONE	HWC	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR		Required Intervention