MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: DHS/DCS BLADE; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - nail head elements: dhs/dcs blade/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.Without a lot number, the device history records review could not be completed as no product was received.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.

Event Description

It was reported on (b)(6) 2021, the patient underwent removal of a dhs plate due to fracture at the distal end.The coupling screw has not been able to be removed from the wrench.It was unknown if the surgery completed successfully.Patient outcome is unknown.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) unk - nail head elements: dhs/dcs blade.This report is 1 of 3 (b)(4).Related product complaint: (b)(4).

Event Description

This report is 3 of 3 (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: DHS/DCS BLADE
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): 1303 GOSHEN SYNTHES USA PRODUCTS LLC; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 11866433
• MDR Text Key: 252135424
• Report Number: 2530088-2021-00002
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention