MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG LEFT CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	2544-00-014
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 on (b)(6) 2021, the patient underwent tka for left oa.During the surgery, when the surgeon performed an osteotomy with the instruments, a large amount of metal debris was generated, and the bone stained black.The surgeon suspected that the material had changed and commented that the material of the instruments had become less expensive.When an osteotomy was performed with a notch guide, an osteotomy was performed with a reciprocating saw, but the metal part was severely abraded.Also, the precision of the slit seemed to be poor, and a large amount of metal debris was generated.The surgeon used a 1.19 mm blade.The clearance with the slit was large, and the surgeon also operated not to touch the slit.The surgeon stated that even a new instrument did not do this.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 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 : examination of the returned device confirms scratches present on the device.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a review of the products¿ design history was conducted and found no changes to the materials for these products.A dhr review was conducted and is attached to this memo.

• Brand Name: ATTUNE 0 DEG LEFT CUT BLOCK
• Common Device Name: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11890311
• Report Number: 1818910-2021-11305
• Device Sequence Number: 3400352
• Product Code: HTZ
• UDI-Device Identifier: 10603295421078
• UDI-Public: 10603295421078
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2021

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: 2544-00-014
• Device Catalogue Number: 254400014
• Device Lot Number: PG290660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 10/11/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/12/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1