MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Catalog Number	226777000
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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.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 lcs impactors are worn out.There was no patient involvement.
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.H11 additional narrative: added: d4 (lot) corrected: b3, d4 (primary udi number).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 : according to the information received, " worn out lcs impactors." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that ' 226777000, hp femoral impactor had worn out.The observed condition of the device was consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the hp femoral impactor would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to end of life 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 complaint condition.As part of 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 : the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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: according to the information received, " worn out lcs impactors." the product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that ' 226777000, hp femoral impactor had worn out.The observed condition of the device was consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the hp femoral impactor would contribute to the complained device issue.Based on the investigation findings, the potential cause can be attributed to end of life 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 complaint condition.As part of 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: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: corrected: h6 (medical device problem code).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: worn out lcs impactors.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the distal end was heavily stripped.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.A functional test was not conducted due to not being applicable to the complaint condition a dimensional inspection was not conducted due to not being applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the hp femoral impactor would have contributed to the complained 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 lot: ht0209 is not a valid finished goods lot number; therefore, a manufacturing records evaluation (mr e) was not performed.

• Brand Name: HP FEMORAL IMPACTOR
• Common Device Name: KNEE INSTRUMENT : 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20385476
• Report Number: 1818910-2024-20968
• Device Sequence Number: 7944793
• Product Code: HWA
• UDI-Device Identifier: 10603295108948
• UDI-Public: (01)10603295108948(10)HT0209
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,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: 226777000
• Device Lot Number: HT0209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 10/17/2024; 11/06/2024; 12/18/2024; 12/20/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/09/2024; 10/18/2024; 11/07/2024; 12/19/2024; 12/23/2024
• 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