MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TIBIAL ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). This report is for an unk - nails: tibial/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 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

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient had an infection who got protect tibial nail on a primary open fracture. Concomitant device reported: unk - screws: (part# unknown; lot# unknown; quantity: unknown). This complaint involves one (1) device. This report is for (1)unk - nails: tibial. This report is 1 of 3 for (b)(4).

• Brand Name: UNK - NAILS: TIBIAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12568017
• MDR Text Key: 274453971
• Report Number: 8030965-2021-08310
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/04/2021 Patient Sequence Number: 1

Treatment

UNK - SCREWS: TRAUMA