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	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 the tibial left cutting block had a rough place from the saw blade on the medial side of block.This could rip gloves as it was passed.They returning, no one was injured, surgery was not delayed.They had 2 articular surface pieces that was broken, unfortunately this did happen in surgery, they were mistakenly disposed of during wash cycle, do not had these to return.Surface pieces racked in 2 pieces, this did not delay surgery, no one was injured and not returning these, as they never appeared after wash.They had pictures of each item.No surgical delay.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).Where the lot code was provided, 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.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : update 15-feb-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device revealed deformation at the corner of the cutting slot.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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 11020845
• Report Number: 1818910-2020-27085
• Device Sequence Number: 17045655
• Product Code: HTZ
• UDI-Device Identifier: 10603295421078
• UDI-Public: 10603295421078
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2020

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: PG233247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 02/01/2021; 03/01/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/12/2021; 02/11/2021; 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1