MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DSTL FEM TRL LO PROFILE RT; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2987-14-105
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
It was reported that on (b)(6) 2021 surgeon was putting an lps distal femur trail together.He used a x-sm right distal femur trial and a x-sm hinge pin and noticed that the hinge pin was having a difficult time passing through the femur.After further inspection after the case, both the hinge pin and inner part of the femur are damaged and need to be replaced.There were no broken pieces and all components were fully intact.
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).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.Added: b5 and h6 (device).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
Question: 1.Please clarify what you mean by damage? is it cracked? bent? stripped or etc? 2.The der is marked "all parts were retrieved".For pieces being retrieved from patient.Please verify if this was marked by mistake or the instrument broke and was left in the patient? answers for your question: 1.The inner piece of the femur, where the hinge pin slides through had been deformed in some way.The pin would not slide through.2.The initial trials were not broken into pieces.By saying that all parts were retrieved.I am saying, that all the damaged trials were received.And sent to our cincinnati office.Nothing was broken off into multiple pieces.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device was unable to replicate the reported event.However off label use was identified.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS DSTL FEM TRL LO PROFILE RT
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12221109
• Report Number: 1818910-2021-15953
• Device Sequence Number: 11805415
• Product Code: HWT
• UDI-Device Identifier: 10603295157830
• UDI-Public: 10603295157830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/07/2021

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 Model Number: 2987-14-105
• Device Catalogue Number: 298714105
• Device Lot Number: AF1399337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 07/23/2021; 08/19/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 07/28/2021; 07/30/2021; 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1