MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN REV DOME DRILL 35MM; DRILLS

Catalog Number	227435800
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: h3, h6: product investigation: the product was returned to medtech orthopaedics for evaluation.Visual examination of returned device revealed the tip broken from pin rev dome drill 35mm due to repeated use.Broken fragment was not returned for evaluation.Additionally, heavy use patterns could be observed on the overall device surface.Breakage of the tip is consistent with multiple uses under extreme eccentric loading resulting in premature bending or failure of the drill bit.However taking in consideration the appearance of the device, the potential cause can be attributed to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Furthermore, based on the appearance of the device, it is not unreasonable to confirm a dull condition on the device cutter surface.As the device was used during surgery with this kind of conditions, which is not indicated on the ifu, condition has been traced to user.Please review the ifu-0902-00-721 rev.L, as "instruments should be carefully inspected before use to ensure that they are fully functional.Scratches or dents can result in breakage.Dullness of cutting edges can result in poor functionality.Damaged instruments should be repaired or replaced to prevent potential patient injury such as loss of metal fragments into the surgical site".A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the pin rev dome drill 35mm would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of medtech orthopaedics 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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.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 procedure the drill was found to be blunt during use so a different drill from the same set was used.There was no patient consequence and no surgical delay.During manufacturer's investigation of the returned device it was revealed that the tip broken from pin rev dome drill 35mm.

• Brand Name: PIN REV DOME DRILL 35MM
• Common Device Name: DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21732999
• Report Number: 1818910-2025-04764
• Device Sequence Number: 15652898
• Product Code: HTW
• UDI-Device Identifier: 10603295109181
• UDI-Public: (01)10603295109181(10)PG302314
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 227435800
• Device Lot Number: PG302314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown