MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIB PREP & IMPACT; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Catalog Number	254501702
Medical Device Problem Codes	Peeled/Delaminated (1454); Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that peeling trays and cut block unable to use due to surface damage.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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).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.Added: a1, b5, h6 medical device problem code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (health effect - clinical code & health effect - impact code).
Event or Problem Description
Additional information n received: a.Was there any adverse consequences that affected the patient because of the reported event? no.B.Was there a surgical delay? if yes, what is the duration of the delay? no.C.Can you please clarify what do you mean by ¿damaged¿? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction.Gouge in block.D.Event description states that "cut block unable to use due to surface damage." please clarify what you mean by damaged.Was it broke, cracked, bent or any other deficiency with the device that was not function as intended? deep lacerations.

• Brand Name: ATTUNE TIB PREP & IMPACT
• Common Device Name: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18985636
• Report Number: 1818910-2024-06784
• Device Sequence Number: 2894936
• Product Code: FSM
• UDI-Device Identifier: 10603295423522
• UDI-Public: 10603295423522
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2024

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: 254501702
• Device Lot Number: 69416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 04/14/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/05/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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