MAUDE Adverse Event Report: SYNTHES GMBH GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1

Catalog Number 292.620

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/07/2022

Event Type  malfunction  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.(510k)device is not distributed in the united states, but is similar to device marketed in the usa.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.

Event Description

Device report from synthes reports an event in united kingdom as follows: it was reported on (b)(6) 2022, that the cannulated drill has a guidewire stuck within the cannulated section.Numerous attempts have been made to remove the wire but has not been successful and therefore has flagged by the account as being damaged and needing replacement.Does not seem to be any evidence of poor use or mistreatment and did not impact patient care due to having another instrumentation set available at the time.The account has not passed on any information regarding the surgeon involved or patient details.This report is for one (1)guidewire ø1.25 w/thread-tip w/trocar l1 this is report 2 of 2 for complaint (b)(4).

Event Description

It was reported that on november 7, 2022, the cannulated drill had a guidewire stuck within the cannulated section.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B5: event description updated to reflect new event date.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: GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1
• Type of Device: GUIDE
• 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: 15920903
• MDR Text Key: 306927662
• Report Number: 8030965-2022-10669
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• 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: 2.7MM CANNULATED DRILL BIT QC 160MM.