MAUDE Adverse Event Report: SYNTHES GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL

Catalog Number 292.62

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional procode: hty.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) 2020 during a compact foot av procedure, 3.5 cannulates were used in which only one (1) 2.7 drill bit came and it was blunt.The surgeon passed one (1) guide of 1.25 and proceeded to drill but due to the lack of sharpness the needle bent.Another guide was requested and it was commented that the surgeon had to use strong force and that may have caused the guide to break.Fragments were generated ad a part remained inside the patient.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed with the use of another drill.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 2 of 3 for (b)(4).

Event Description

Additional event information: the reported issue did not caused any impact to the patient.There was no additional intervention schedule to remove broken pieces from the patient.The mentioned needle that was bent is refers to the guidewire.The patient outcome was good.

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.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 history lot nov 02, 2020.Device history review part: 292.620, lot: 61p3420, manufacturing site: balsthal, release to warehouse date: jul.14, 2020.A manufacturing record evaluation was performed for the finished device lot number 61p3420, and no non-conformances were identified.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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10774602
• MDR Text Key: 214397094
• Report Number: 8030965-2020-08503
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.62
• Device Lot Number: 61P3420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.7MM CANNULATED DRILL BIT QC 160MM; UNK - GUIDE/COMPRESSION/K-WIRES; 2.7MM CANNULATED DRILL BIT QC 160MM; UNK - GUIDE/COMPRESSION/K-WIRES
• Patient Age: 57 YR
• Patient Weight: 76