MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM

Catalog Number	03.130.302
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/08/2024
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.H11 additional narrative: e3: reporter is a j&j employee.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during surgery on (b)(6) 2024, the 1.5mm drill bit from the va hand set was broken.It broke into two pieces, and around 1cm of the broken drill bit was left inside the patient¿s bone and could not be retrieved.The surgery was completed successfully with no delay, and the patient status was reported to be normal.No additional medical intervention was required.This report involves one 1.5mm drill bit/mqc for threaded hole/74mm.This is report 1 of 1 for (b)(4).
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.H11 additional narrative: 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 tip of the drill bit ø1.5 l74/57 f/core hole was broken, fragment was not received for evaluation.No other issues were identified.The allegation of embedded device was not confirmed as no postoperative images to assess the condition were provided.A dimensional inspection for the drill bit ø1.5 l74/57 f/core hole was not 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 drill bit ø1.5 l74/57 f/core hole would 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.Device history review (dhr): product code: : 03.130.302.Lot number : f-35895.Release to warehouse date : 23.Sep.2022.Expiration date : na.Supplier: (b)(6).Manufacturing site: werk selzach logistik.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Corrected data: g1: manufacture site updated.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: 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19458557
• Report Number: 8030965-2024-07044
• Device Sequence Number: 18122101
• Product Code: HTW
• UDI-Device Identifier: 07611819690783
• UDI-Public: (01)07611819690783
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.130.302
• Device Lot Number: F-35895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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
• Patient Sex: Unknown