MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLEN DRILL GUIDE D 2.5MM; DRILL GUIDES

Catalog Number	230790003
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.Additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.¿visual inspection of the returned device found the weld between cannulated drill sleeve and handle broke.As a result, the cannulated drill sleeve detached and was not returned for evaluation.¿a previous investigation was conducted for a similar fracture of the welded region connecting the arm and the cannulated sleeve.Scanning electron microscopy (sem) was performed on the fractured surface on the sleeve surface.The evaluation determined the fracture of the drill guide was caused by overload.The fracture indicated that single bending force was applied in a direction to cause opening of the obtuse angle between the arm and the sleeve and this force was exceeding the ultimate strength of the material.The root cause of the current reported event is being attributed to unintended use.¿ a root cause the missing components can not be established.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 glen drill guide d 2.5mm would have contributed to a 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 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 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 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
A device was received for analysis.There was no product malfunction or patient harm reported with the returned device.

• Brand Name: GLEN DRILL GUIDE D 2.5MM
• Common Device Name: DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21349205
• Report Number: 1818910-2025-02424
• Device Sequence Number: 8959291
• Product Code: LXH
• UDI-Device Identifier: 10603295116523
• UDI-Public: (01)10603295116523(10)5365328
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 230790003
• Device Lot Number: 5365328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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