MAUDE Adverse Event Report: SYNTHES GMBH UNK - GUIDE/COMPRESSION/K-WIRES; WIRE, SURGICAL

Device Problem Material Deformation (2976)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in australia as follows: it was reported that on (b)(6) 2023, during a ipj fusion, when drilling for the screw the drill bit broke into pieces.The bits were removed as best as possible and fresh drill bit was used from another kit.The screw was inserted successfully.On final x-rays there was not visible remnants of the broken drill bit.When guide wire was removed it was identified to have a slight bend to it.There was a surgical delay of thirty minutes.The procedure was completed successfully.There was no patient consequence.This report involves unknown guide/compression/k-wires: trauma.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D1, d2, d3, d4, g4-510k: this report is for an unknown guide/compression/k-wires/unknown lot.Part and lot number are unknown.Without the specific part number.The udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 therapy date: (b)(6) 2023.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17940164
• MDR Text Key: 325741624
• Report Number: 8030965-2023-12953
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE F/
• Patient Sex: Male