MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK DRILL; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	UNK DRILL
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the flexible drill holder drill broke off; the rest is stuck.There was no patient harm reported.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 that 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, " customer has a flexible drill holder in which the drill has been broken off.The rest is still stuck".The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that a drill (unk part and lot) was jammed and broken inside the couple section of the quickset flex dr sft qck cple.Broken fragment was not 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 breaking of the drill bit.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the unk drill would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use, and it has been determined that no corrective and/or preventative action is required.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 device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.1) quantity manufactured: (b)(4).2) date of manufacture: 02/22/2024.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu-0902-00-721.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified during manufacturing.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 02/22/2024.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu-0902-00-721.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review : a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, " customer has a flexible drill holder in which the drill has been broken off.The rest is still stuck".The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the quickset flex dr sft qck cple was not broken, only wear marks were found as normal use.However, a fragment of its mating device was found inside the couple section.The observed condition of the device was consistent with exposure to unintended forces, such as extreme eccentric loading, which could result in premature breaking of the drill bit.A functional test was performed, and it was observed that the fragment within the coupler was jammed.It is suspected that the breakage of the mating device is preventing the mechanism from releasing it as intended.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the quickset flex dr sft qck cple would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use, and it has been determined that no corrective and/or preventative action is required.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 02/22/2024.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu-0902-00-721.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 02/22/2024.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu-0902-00-721.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
The device malfunction, device interaction (2+ devices) : jammed/seized, will no longer be reported as there has not been a serious injury associated with this failure within the past 2 years.Please consider this the last manufacturer report number submitted against this malfunction.H11 additional narrative: corrected: d1 and d4 (catalog).

• Brand Name: UNK DRILL
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• 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: 22286539
• Report Number: 1818910-2025-10046
• Device Sequence Number: 8458451
• Product Code: HTW
• UDI-Device Identifier: 10603295109273
• UDI-Public: (01)10603295109273(10)SO2065022
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,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: UNK DRILL
• Device Lot Number: SO2065022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 07/15/2025; 08/14/2025; 08/20/2025; 09/24/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/17/2025; 08/15/2025; 08/22/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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