MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LIGHT SLOTTED HAMMER; KNEE INSTRUMENT : IMPACTION INSTRUMENTS

Catalog Number	242122000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
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.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent the surgery via tha for oa for the hip joint with the product in question.During surgery, when the surgeon was performing stem rasping with the product in question, the base of the hammer broke.There were no broken parts left inside the body, and a different hammer was used without affecting the surgery.The surgeon opined that the cause of the breakage was likely due to metal fatigue.The surgery was completed successfully without any surgical delay.No further information is available.
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 that 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.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, "it was reported that on (b)(6) 2024, the patient underwent the surgery via tha for oa for the hip joint with the product in question.During surgery, when the surgeon was performing stem rasping with the product in question, the base of the hammer broke.There were no broken parts left inside the body, and a different hammer was used without affecting the surgery.The surgeon opined that the cause of the breakage was likely due to metal fatigue." the product was not returned to depuy synthes, however photos were provided for review.See attachment photo (b)(4).(b)(6) hospital.The photo investigation revealed that light slotted hammer was broken at weld junction between shaft and head.Review of provided photo shows the broken condition of device however with the available evidence exact potential cause cannot be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the light slotted hammer would contribute to the complained device issue.Based on the investigation findings, potential cause not established 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 depuy synthes 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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported, that on feb 13, 2024.The patient underwent the surgery via tha for oa, for the hip joint with the product in question.During surgery, when the surgeon was performing stem rasping with the product in question, the base of the hammer broke.There were no broken parts left inside the body.And a different hammer was used without affecting the surgery.The surgeon opined, that the cause of the breakage was likely, due to metal fatigue.The surgery was completed successfully without any surgical delay.No further information is available.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection revealed, that the light slotted hammer had the head broken and handle broken at the weld junction.Additionally, the hammer head (poly and metal portion) was found with heavy worn patterns attributed to heavy high cycle impaction.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 not performed, since it was not applicable to the complaint condition.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 light slotted hammer would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life.And it has been determined, that no corrective and/or preventative action is required.As part of depuy synthes 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: LIGHT SLOTTED HAMMER
• Common Device Name: KNEE INSTRUMENT : IMPACTION 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 46581-0988 ; 3035526892
• MDR Report Key: 18730893
• Report Number: 1818910-2024-03669
• Device Sequence Number: 12526671
• Product Code: FZY
• UDI-Device Identifier: 10603295122906
• UDI-Public: 10603295122906
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/19/2024

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: 242122000
• Device Lot Number: JG715A42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 02/20/2024; 03/12/2024; 03/22/2024; 05/09/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 02/22/2024; 03/13/2024; 03/25/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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