MAUDE Adverse Event Report: SYNTHES GMBH DRIVING CAP/THREADED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 03.010.523

Device Problem Break (1069)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3/h6: investigation summary: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified device history lot: part# 03.010.523.Lot # 9519944.Manufacturing site: werk bettlach.Supplier; na.Release to warehouse date: 26 aug 2015.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that '03.010.523, driving cap/threaded had broken tip.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the driving cap/threaded would contribute to the complained device issue.Based on the investigation findings, caused traced to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

It was reported that on (b)(6) 2024, the threads at end of the driving cap that screw into the insertion handle broke off in the handle while striking the driving cap with a mallet, leaving the black tip of the driving cap stuck in the threads of the handle.Outcome of the surgery was as consented, and the surgery was completed successfully.This report is for one (1) driving cap/threaded.This is report 1 of 2 for complaint (b)(4).

• Brand Name: DRIVING CAP/THREADED
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19202010
• MDR Text Key: 341849640
• Report Number: 8030965-2024-05493
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982069351
• UDI-Public: (01)10886982069351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.523
• Device Lot Number: 9519944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: RADIOLUCENT INSERTION HANDLE FRN