MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 3.8 DIMTR DR BLT 40MM; DRILLS

Catalog Number	227457000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the 40 mm bit was broken, and the pinnacle impactor was broken.
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.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).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: b5.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
Additional information received: a.Were fragments generated? if so, were all fragments recovered? - if a fragment of the bit was generated, but it was recovered.The two pieces fractures were sent from the pinnacle impactor.B.Did it break into two or more pieces? if not, specify the alleged deficiency of the instrument.Is it bent, cracked, worn or with the cross thread? - yes, the two pieces broke.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary.According to the information received that "40 mm bit is broken.Pinnacle impactor is broken." the product was not returned to medtech orthopedics; however, photos were provided for review.See attachment "source file - repiorte novedad colectivo 562903 soma.¿ the photo investigation revealed that 'quickset 3.8 dimtr dr blt 40mm' has broken.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces such as drilling in an misaligned position, extreme eccentric loading resulting in premature bending or failure of the drill bit, heavy usage, prying motion.Properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the quickset 3.8 dimtr dr blt 40mm would contribute to the complained device issue.Based on the investigation findings, the ¿quickset 3.8 dimtr dr blt 40mm¿ has ¿intraoperatively broken (2+ pieces)¿ because of unintended user 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 complaint condition.As part of medtech orthopedics 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.

• Brand Name: QUICKSET 3.8 DIMTR DR BLT 40MM
• 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: 23072806
• Report Number: 1818910-2025-15999
• Device Sequence Number: 9738361
• Product Code: HTW
• UDI-Device Identifier: 10603295109327
• UDI-Public: (01)10603295109327(10)NG88558
• 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: 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: 227457000
• Device Lot Number: NG88558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 01/21/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/23/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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