MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 POLY TIB COMP IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Catalog Number	966385
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
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
Part of plastic component broke off.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, part of plastic component broken off.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device 966385, sp*2 poly tib comp impactor has broken.Based on the observed appearance of the device in the image attached, potential cause for the reported event can be attributed to end of life.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 966385, sp*2 poly tib comp impactor would contribute to the complained device 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 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 : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code j0105 provided is not a valid finished goods lot.
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 corrected: h3 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, part of plastic component broken off.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation revealed that the device 966385, sp*2 poly tib comp impactor has broken.Based on the observed appearance of the device in the image attached, potential cause for the reported event can be attributed to end of life.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 966385, sp*2 poly tib comp impactor would contribute to the complained device 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 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code j0105 provided is not a valid finished goods lot.

• 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18234485
• Report Number: 1818910-2023-24303
• Device Sequence Number: 20623205
• Product Code: HWA
• UDI-Device Identifier: 10603295248279
• UDI-Public: (01)10603295248279(10)J0105
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2023

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: 966385
• Device Lot Number: J0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 05/28/2024; 07/22/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/05/2023; 05/29/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2005
• 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