FDA Adverse Event Malfunction Summary report: N

UNK - GUIDE/COMPRESSION/K-WIRES

MDR report key: 11733925 · Received April 27, 2021

Report

Report Number: 2939274-2021-02102
Event Type: Malfunction
Date Received: April 27, 2021
Date of Event: April 1, 2021
Report Date: April 1, 2021
Manufacturer: WRIGHTS LANE SYNTHES USA PRODUCTS LLC
Product Code: JDS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT COMPLAINT # (B)(4). PMA/510K: THIS REPORT IS FOR AN UNK: GUIDE/COMPRESSION/K-WIRES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2021, THE UNKNOWN GUIDEWIRE BECAME LODGED INSIDE THE RFN-ADVANCED RETROGRADE FEMORAL NAILING WHEN WE ARE ABLE TO FINALLY REMOVE IT. THE PEAK INLAY AT THE DISTAL END OF THE NAIL CAME OUT WITH THE UNKNOWN GUIDEWIRE. NO ADVERSE EFFECT TO THE PATIENT OR TO THE CASE OR DURING THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)UNK - GUIDE/COMPRESSION/K-WIRES. THIS REPORT IS 2 OF 2 (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
629980	UNK - GUIDE/COMPRESSION/K-WIRES	NAIL, FIXATION, BONE	JDS	WRIGHTS LANE SYNTHES USA PRODUCTS LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1				RFNA / 9 / 340 5 DEG BEND / STERILE