MAUDE Adverse Event Report: SYNTHES GMBH SHAFT FOR 90 SCREWDRIVER

Catalog Number	03.505.003
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2023
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample found no damage or defect found related to reported issue.Furthermore a foreign unknown substance is found on the fluted tip of inner shaft; root cause of this condition cannot be established with information available.A functional test was unable to be completely performed without turning handle (product code: 03.505.005).However, shaft and handle for 90 screwdriver that were returned in an assembled condition, can be disassembled with no problem or difficulty.Inner shaft component of the shaft can also be assembled and disassembled in a correct matter.A dimensional inspection was unable to be performed due to the condition of the complaint.The overall complaint was unconfirmed as the observed condition of the shaft for 90 screwdriver would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.H3, h4, h6: device history record (dhr) review conducted: product code: : 03.505.003; lot number : 8216382; release to warehouse date : 17.Aug.2022; expiration date : na; supplier: (b)(4).Manufacturing site: werk selzach; a manufacturing record evaluation was performed for the finished article lot 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
Device report from depuy synthes reports an event in japan as follows: it was reported that during a sagittal split ramus osteotomy (ssro) performed on (b)(6) 2023, the instruments in question were assembled and rotated as a screwdriver, however they did not rotate.Other instruments were assembled as a drill, and they were used as a screwdriver instead of the instruments in question.The surgery was completed successfully within thirty (30) minutes delay.Patient outcome is reported as stable.No further information is available.During manufacturer's investigation of the returned device it was identified that a foreign unknown substance was on the fluted tip of inner shaft.This report is for one (1) shaft for 90° screwdriver.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SHAFT FOR 90 SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18907477
• Report Number: 8030965-2024-03675
• Device Sequence Number: 6410960
• Product Code: HXX
• UDI-Device Identifier: 10887587013299
• UDI-Public: (01)10887587013299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082649
• 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: 03.505.003
• Device Lot Number: 8216382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: HANDLE FOR 90 SCREWDRIVER; TURNING HANDLE
• Patient Sex: Unknown