MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM STARDRIVE SCREWDRIVER SHAFT

Catalog Number	314.451
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned revelated that the scrdriver shaft 2.4 short self-holding was worn from the tip.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed worn condition of scrdriver shaft 2.4 short self-holding would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review part number: 314.451 lot number: 398p175 manufacturing site: haegendorf release to warehouse date: 21.09.2021 a manufacturing record evaluation was performed for the finished device lot 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.
Event or Problem Description
It was reported that on (b)(6) 2023, there were problems with the metal removal of a dorsal distal tibial plate.The reason for the attempted hardware removal was that the patient wanted the material removed from osteosyntheses in 2020.Several screwdrivers/attachments were demolished while trying to remove the screws.The physician was unhappy that the screws had to remain in the patient, and there was a surgical delay of approximately one hour.No other medical intervention was required, but the surgery was not completed successfully, as the osteosynthesis material remained in the bone.After visual examination of the returned products on (b)(6) 2023, it was found that additional devices were stripped.This report involves one 2.4mm stardrive screwdriver shaft.This is report 6 of 6 for (b)(4).

• Brand Name: 2.4MM STARDRIVE SCREWDRIVER SHAFT
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17031773
• Report Number: 8030965-2023-06856
• Device Sequence Number: 20447952
• Product Code: HXX
• UDI-Device Identifier: 07611819137660
• UDI-Public: (01)07611819137660
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Catalogue Number: 314.451
• Device Lot Number: 398P175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCRDRIVER SHAFT 3.5 T15 SELF-HOLDING F/A; SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH; SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH; SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH; UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA
• Patient Age: 44 YR
• Patient Sex: Unknown