MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 54MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	221890054
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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.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 the broken tab on pinnacle ab gripper 54mm.Opened second tray for back up instrument only to find 54mm gripper on second tray also had a broken tab.This would have also occurred prior to this case.Was able to still implant and seat liner but concern over structural integrity of gripper for future cases.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received, "broken tab on pinnacle ab gripper 54mm.Opened second tray for back up instrument only to find 54mm gripper on second tray also had a broken tab." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that pinnacle 54mm gripper had broken.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the pinnacle 54mm gripper would contribute to the complained device issue.Based on the investigation findings, potential cause attributed to component failure 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 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.Device history batch: null.Device history review: null.
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.H10 additional narrative: added: d9.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: broken tab on pinnacle ab gripper 54mm.Opened second tray for back up instrument only to find 54mm gripper on second tray also had a broken tab.This would have also occurred prior to this case.Was able to still implant and seat liner but concern over structural integrity of gripper for future cases.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed one prong broken from the pinnacle 54mm gripper.Broken fragment was not returned for evaluation.Additionally, the device shows signs of usage according to its time of service.The observed condition was identified as an end-of-life indicator, damage consistent with repeated use and servicing.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, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the pinnacle 54mm gripper would have 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: 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.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: according to the information received, "broken tab on pinnacle ab gripper 54mm.Opened second tray for back up instrument only to find 54mm gripper on second tray also had a broken tab." the product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that pinnacle 54mm gripper had broken.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the pinnacle 54mm gripper would contribute to the complained device issue.Based on the investigation findings, potential cause attributed to component failure 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 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: PINNACLE 54MM GRIPPER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21893161
• Report Number: 1818910-2025-06253
• Device Sequence Number: 8154690
• Product Code: LXH
• UDI-Device Identifier: 10603295102298
• UDI-Public: (01)10603295102298(10)SO2004852
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/23/2025

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: 221890054
• Device Lot Number: SO2004852
• 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: 03/30/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 06/09/2025; 06/17/2025; 06/18/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/25/2025; 06/10/2025; 06/18/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2001
• 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