MAUDE Adverse Event Report: SYNTHES GMBH 4.3MM DRILL BIT LENGTH 413MM; SURGICAL BIT

Catalog Number	03.168.011
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2023, the parts were damaged during surgery.Upon inspection of the returned products on (b)(6) 2024, it was noted that the two drill bit ø4.3 l413s were broken.This report involves one 4.3mm drill bit length 413mm.This is report 3 of 3 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.E3: reporter is a j&j employee.H3, h4, h6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that there were no damage or defect with the drill bit ø4.3 l413, the images do not provide enough evidence to confirm the alleged reported condition or any other issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed or drill bit ø4.3 l413.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.Physical device investigation: 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 flute tip of the drill bit ø4.3 l413 was found broken.The broken tip was returned.A dimensional inspection 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 excessive/unintended forces.The overall complaint was confirmed as the observed condition of the drill bit ø4.3 l413 would contribute to the complained device issue.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.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.Device history review (dhr): part: 03.168.011.Lot: f-30464.Manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: 09 sep 2020.Expiration date: na.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.

• Brand Name: 4.3MM DRILL BIT LENGTH 413MM
• Common Device Name: SURGICAL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18701608
• Report Number: 8030965-2024-02382
• Device Sequence Number: 12301080
• Product Code: GFG
• UDI-Device Identifier: 07611819657373
• UDI-Public: (01)07611819657373
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional
• 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: 03.168.011
• Device Lot Number: F-30464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown