MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM

Catalog Number	03.010.078
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4) 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: a device history record (dhr) review requested.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 on (b)(6) 2024, the patient underwent an orif surgery.The guide rod and the drill bit interfered and the tip of the drill bit broke off when drilling without removing the guide rod after inserting the nail over it.The surgeon removed the nail once because the broken drill bit was left in the body, removed the broken drill bit, and reinserted implants including the nail.The surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) 4.5mm/6.5mm stepped drill bit large qc/485mm this is report 2 of 2 for complaint (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.D9 h3, h6: part:03.010.078 lot:f-27490 manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: 01 jul 2019.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the reamer ø4.5/6.5 l484 f/hip screws lfn was found broken from the fluted tip.The broken fragments were not returned for examination.No other issues were observed.The misalignment condition can be confirmed because it is reasonable to conclude that the guide and the drill bit were not aligned, which caused the damage.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional evaluation was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the reamer ø4.5/6.5 l484 f/hip screws lfn 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.There is no indication that a design or manufacturing issue has caused the reported 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.Corrected data: g1: manufacturing site name and address.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: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19564022
• Report Number: 8030965-2024-07630
• Device Sequence Number: 6197821
• Product Code: HTW
• UDI-Device Identifier: 07611819765702
• UDI-Public: (01)07611819765702
• 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: 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: 03.010.078
• Device Lot Number: F-27490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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: UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: TRAUMA
• Patient Sex: Unknown