MAUDE Adverse Event Report: SYNTHES GMBH BEND-IRON F/K-WIRES F/WIRES 1.25-2.5; INSTR,BENDING OR CONTOURING

Model Number 392.00

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that on an unknown date, the kirshner could not be removed.This report involves one (1) bend-iron f/k-wires f/wires ø1.25-2.5.This is report 1 of 1 for (b)(4).

• Brand Name: BEND-IRON F/K-WIRES F/WIRES 1.25-2.5
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11567927
• MDR Text Key: 280452974
• Report Number: 8030965-2021-02289
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 10886982198594
• UDI-Public: (01)10886982198594
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 392.00
• Device Catalogue Number: 392.000-US
• Device Lot Number: 2038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1