MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE SCRWDRVR BLADE SHORT/NON SELF-RETAINING; SCREWDRIVER

Catalog Number	03.503.066
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
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.E1: initial reporter facility name: (b)(6).H3, h4, h6: 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 sample revealed that the hex coupling tip of the scrdriver shaft matmand short not self-h was found broken and severely deformed.The broken fragments were not returned for evaluation.No other defects that could have contributed to the reported condition were observed.A dimensional inspection for the scrdriver shaft matmand short not self-h was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 condition of the scrdriver shaft matmand short not self-h would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 (dhr): part: 03.503.066; lot no:3354983; release to warehouse date: 28 jan 2010; manufacturing site: werk hagendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformance's 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 synthes reports an event in japan as follows: it was reported that during a removal surgery performed on (b)(6), 2023, the surgeon attempted to extract the matrix rib screw with the screwdriver and sleeve, but the screw was too tight to be extracted, partly because it had been some time since it was inserted.The surgeon tried several screwdrivers and sleeves.The surgeon also felt that those instruments got bent.The screw was eventually extracted by using a carbide drill, and the surgery was completed successfully with a less than 30-minute delay.The patient outcome was reported to be stable.Upon manufacturer investigation of the returned device, it was identified that the returned screwdriver shaft was broken.This report involves one matrixmandible scrwdrvr blade short/non self-retaining.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE SCRWDRVR BLADE SHORT/NON SELF-RETAINING
• 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: 18048503
• Report Number: 8030965-2023-13675
• Device Sequence Number: 12629549
• Product Code: HXX
• UDI-Device Identifier: 07611819961890
• UDI-Public: (01)07611819961890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 03.503.066
• Device Lot Number: 3354983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2010
• 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: HOLD-SL SHORT F/03.503.066; HOLD-SL SHORT F/03.503.066; SCRDRIVER SHAFT MATMAND LONG SELF-HOLDIN; SCRDRIVER SHAFT MATMAND LONG SELF-HOLDIN; SCRDRIVER SHAFT MATMAND MED SELF-HOLDING; SCRDRIVER SHAFT MATMAND MED SELF-HOLDING; SCRDRIVER SHAFT MATMAND SHORT NOT SELF-H; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown