MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CALCAR MILL SMALL; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Catalog Number	200147000
Medical Device Problem Codes	Failure to Cut (2587); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent total hip replacement on (b)(6) 2024.The calcar planar needed to be used multiple times because it is worn out and dull.Another instrument set was opened to get a new one.There was an unknown surgical delay.There was no patient consequence.
Additional Manufacturer Narrative
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
Event or Problem Description
Additional information received and stating that: a.What was the exact allegation against the product? - it was just spinning on the bone.B.Was there any surgical delay? - yes, we had to open another instrument set to get a new one.C.Was there any patient harm reported? - no.
Additional Manufacturer Narrative
The device malfunction, visual: stripped/twisted/cross threaded, 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.

• Brand Name: CALCAR MILL SMALL
• Common Device Name: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• 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 ; 3035526892
• MDR Report Key: 20517772
• Report Number: 1818910-2024-22088
• Device Sequence Number: 8855552
• Product Code: LYS
• UDI-Device Identifier: 10603295080008
• UDI-Public: (01)10603295080008
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Physician
• 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: 200147000
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 08/15/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/31/2024; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female