MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER SHAFT T8 55MM

Catalog Number 314.453

Device Problems Mechanical Problem (1384); Device-Device Incompatibility (2919)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported on (b)(6), 2024, the patient underwent orif surgery for distal radius fracture with screwdriver shaft.During surgery, the screwdriver shaft was difficult to attach to the screw head during final torque tightening and could not be torqued properly.Therefore, the surgeon replaced it with a different screwdriver shaft and tightened the torque.The surgery was completed successfully, but the surgeon requested that the initial driver shaft be thoroughly checked for appearance to ensure that it is a properly inspected and certified product.The surgery was completed successfully within 30 minutes surgical delay.No medical intervention was required.Patient is listed as stable.This report is for one stardrive screwdriver shaft t8 55mm 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e1: initial reporter is j&j company representative h3, h4, h6 investigation summary photos were provided for review.The photo investigation revealed that the tip of scrdriver shaft 2.4 short self-holding f was stripped and with the present damage device will not be able to hold/retain screw and will not be able to tighten.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the scrdriver shaft 2.4 short self-holding f would contribute to the complained device issue.The device associated with this report was returned to depuy synthes for evaluation.Investigation findings revealed distal tip of the device is stripped.Although it not possible to perform a functional test without mating component, it is not unreasonable that functionality of the device is not working in a correct mode, therefore it is possible to confirm the reported issue.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the scrdriver shaft 2.4 short self-holding f would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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.Drawing/specifications reviewed? reviewed.Dimensional inspection: n/a.Device history: part number: 314.453.Lot number: 723p530.Manufacturing site: hägendorf.Release to warehouse date: 05-april-2022.A manufacturing record evaluation was performed for the finished device batch number, 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: STARDRIVE SCREWDRIVER SHAFT T8 55MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): HÄGENDORF; im bifang 6; hägendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18928866
• MDR Text Key: 337984176
• Report Number: 8030965-2024-03798
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188854
• UDI-Public: (01)10886982188854
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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

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: 314.453
• Device Lot Number: 723P530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA