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

Model Number	03.503.071
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that an unknown surgery was performed on (b)(6) 2023.During surgery, the screwdriver shaft could not hold a screw.The same screwdriver shaft in different lengths in the set was used instead of the screwdriver shaft in question.The surgery was completed successfully without any surgical delay.This is report 1 of 1 for (b)(4).This report is for (1) matrix mandible/thorax scrwdrvr blade self retaining-medium.
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.H3, h4, h6 investigation summary: 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 the screw tip of the device is stripped and worn down.The inability to assemble the device can be attributed with the damaged on the device.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was stripped 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 condition of the [scrdriver shaft matmand med 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.Drawing/specifications reviewed: yes, reviewed.Device history: part # 03.503.071.Synthes lot # u112294.Supplier lot # u112294.Release to warehouse date: 09 nov 2009.Supplier: (b)(4).No ncr's were generated during production.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: MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16985800
• Report Number: 8030965-2023-06494
• Device Sequence Number: 6956714
• Product Code: HXX
• UDI-Device Identifier: 10887587011875
• UDI-Public: (01)10887587011875
• 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 Model Number: 03.503.071
• Device Catalogue Number: 03.503.071
• Device Lot Number: U112294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown