MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CALCAR PLANER LRG; REAMERS

Catalog Number	257004503
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the reamer is damaged.The larger reamer got stuck and would not come off.There was no patient impact.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the larger reamer got stuck and would not come off.The smaller one that also goes on is on they tray no patient impact as they only issue is we couldn¿t get it off at the end.Generally there use the smaller reamer for all cases but in this instance we needed the big.My concern is that if it can¿t come off when it goes to the next place they will have the big reamer in and could port over ream.¿the product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment (b)(4)- re_ customer service report -csr2489837 against rsc theatres (orthopaedic).The photo investigation revealed that the modular calcar planer lrg is attached to another device, no other signs of a device nonconformance were observed.The photo does not provide enough evidence to confirm the reported allegation.Functionality issues of the device cannot be assessed through a photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the modular calcar planer lrg would have not contributed to the complained device issue.Based on the investigation findings, 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 lot a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
Event or Problem Description
Additional information received states that the reamer got stuck on the handle and we could not get it off.No patient consequences and no surgical delay.

• Brand Name: MODULAR CALCAR PLANER LRG
• Common Device Name: REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20323433
• Report Number: 1818910-2024-20352
• Device Sequence Number: 7782615
• Product Code: HWE
• UDI-Device Identifier: 10603295482031
• UDI-Public: (01)10603295482031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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

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: 257004503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/29/2024
• 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: Unknown