MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CONV FB PS TB TRL SZ7; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500977
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
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 decontam has brought to our attention we have several shims and 1 artic surface with sharp edges.They are requesting these items be replaced.There was not a patient in the room when items were discovered damaged.Nobody was injured by damaged items.This did not delay a surgery.All pieces are intact, and are being returned.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Added: d10 (concomitant medical products), h6 (device code).Corrected: h3 (device evaluated by mfr).Product complaint#: (b)(4).Investigation summary: examination of the returned device confirmed the reported damage.The investigation determined the damage was due to normal handling and servicing and did not indicate that a broader investigation or corrective action was necessary.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ7
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co; cork ; EI
• MDR Report Key: 8983591
• Report Number: 1818910-2019-103844
• Device Sequence Number: 19652052
• Product Code: JWH
• UDI-Device Identifier: 10603295135548
• UDI-Public: 10603295135548
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 254500977
• Device Lot Number: BFA0P7Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1