MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM DRILL BIT W/DEPTH MARK QC/110MM; BIT, SURGICAL

Catalog Number	310.534
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H6: photo investigation: the product was not returned to depuy synthes, however photo was provided for review.The photo investigation revealed that the fluted tip of 310.534, drill bit 2 w/marking l110/85 2flute f/ was broken.The allegation of embedded device cannot be confirmed as no post operative images were provided to assess the condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 310.534, drill bit 2 w/marking l110/85 2flute f/ would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: a manufacturing record evaluation was performed for the finished device.Product code: 310.534.Lot number: 7289p41.It was electronically reviewed and no nonconformances / manufacturing irregularities.Were identified during the manufacturing process.The product was released on:11/08/2023.Manufacturing site:jabil bettlach.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 singapore as follows: it was reported that on (b)(6) 2023 a drill bit broke when surgeon trying to use it to drill a hole in the scapular.Surgeon said the drill bit broke because of his maneuver.Surgeon decided to leave the broken part inside patient, as he mentioned that, trying to remove the broken part may cause more harm than leaving it inside.There was no surgical delay.The procedure was successfully completed.Patient outcome is reported as well.This report is for one (1) 2.0mm drill bit w/depth mark qc/110mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.0MM DRILL BIT W/DEPTH MARK QC/110MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18162109
• Report Number: 8030965-2023-14549
• Device Sequence Number: 7322423
• Product Code: GFG
• UDI-Device Identifier: 07611819158962
• UDI-Public: (01)07611819158962
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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

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: 310.534
• Device Lot Number: 7289P41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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