MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT ANGLED INSERTER; HIP INSTRUMENTS : IMPACTORS

Catalog Number	257005125
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 25mm drill bit bent during screw preparation.Both stem inserters mush roomed out during stem insertion.Surgeon was required to knock the inserters out of the shoulder of the stem after insertion.There was a concern that the greater trochanter was fractured.Surgical delay unknown.
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.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 it was reported that 25mm drill bit bent during screw preparation.Both stem inserters mushroomed out during stem insertion.Surgeon was required to knock the inserters out of the shoulder of the stem after insertion.There was a concern that the greater trochanter was fractured.Surgical delay unknown.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that summit angled inserter was severely deformed from the shaft near the tip, the reported allegation can be confirmed.The observed condition of the device can attributed to a combination of heavy use and unintended impaction forces while the device is not fully seated on its mating device.The overall complaint was confirmed as the observed condition of the summit angled inserter would have contributed to the complained issue based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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: SUMMIT ANGLED INSERTER
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18901736
• Report Number: 1818910-2024-05743
• Device Sequence Number: 9050026
• Product Code: HWR
• UDI-Device Identifier: 10603295143222
• UDI-Public: 10603295143222
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2024

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: 257005125
• Device Lot Number: CV175759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 03/27/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/24/2024; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 85 KG