MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 3.8MM DRILL BIT 25MM; DRILLS

Catalog Number	236684000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a tha surgery for osteoarthritis of the right hip.After inserting a pinnacle gription cup, the surgeon drilled with a drill bit for creating a burr hole according to the surgical technique.The drill bit was used with a flexible drill shaft and drill guide.During drilling, the drill bit broke off.The broken fragment of the drill bit left in the body was able to be removed quickly with forceps.It was confirmed by visual inspection that no broken fragments were inside the body, and the surgery was resumed after washing.The hip joint was photographed intraoperatively using portable image intensifier and postoperatively using x-rays, but no large fragments visible to the naked eye were identified in the images.The surgery was completed successfully with no surgical delay.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "it was reported that on (b)(6) 2025, the patient underwent a tha surgery for osteoarthritis of the right hip.After inserting a pinnacle gription cup, the surgeon drilled with a drill bit for creating a burr hole according to the surgical technique.The drill bit was used with a flexible drill shaft and drill guide.During drilling, the drill bit broke off." the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the 3.8mm drill bit 25mm was broken at the middle.The broken fragment was returned for evaluation.The observed condition of the device was consistent with exposure to unintended forces, such as extreme eccentric loading, which could result in premature bending or breaking of the drill bit.A functional test was unable to be performed since it was not applicable to the complaint condition.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 3.8mm drill bit 25mm would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, 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 reported complaint condition.As part of j&j 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.H11 additional narrative: corrected: h3.

• Brand Name: 3.8MM DRILL BIT 25MM
• Common Device Name: DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22139854
• Report Number: 1818910-2025-08972
• Device Sequence Number: 15218856
• Product Code: HTW
• UDI-Device Identifier: 10603295120186
• UDI-Public: (01)10603295120186(10)NG130246
• 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,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: 236684000
• Device Lot Number: NG130246
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 06/19/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/10/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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