MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE REV SLD FB INSRT SZ9-10; INSTRUMENT CASES

Model Number	2549-00-300
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the color of the tray was coming off the tray and was adhering to the instruments during re-processing.Seen in cssd; no adverse patient consequences, no surgical delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however photo(s) were provided for review.Review of the provided photo(s) confirms case peeling.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the pv0148039 is not a valid finished goods lot number; therefore, a manufacturing records evaluation (mre) was not performed.
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.
Event or Problem Description
Additional information was received and confirmed that the paint was peeled off as evidenced by the attached photos.The customer worked around the issue by putting the instruments in another tray/container.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was returned to depuy synthes for evaluation, visual examination found the graphics on the bottom and outer surface of the device peelingoff, however no damage on the coating was found.The reported allegation can be confirmed as these 2 situations can be related.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the pv0148039 is not a valid finished goods lot number; therefore, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE REV SLD FB INSRT SZ9-10
• Common Device Name: INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16831818
• Report Number: 1818910-2023-08905
• Device Sequence Number: 1855625
• Product Code: FSM
• UDI-Device Identifier: 10603295476368
• UDI-Public: 10603295476368
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/27/2023

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 Model Number: 2549-00-300
• Device Catalogue Number: 254900300
• Device Lot Number: PV0148039
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 06/23/2023; 07/12/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/15/2023; 06/26/2023; 07/12/2023
• 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