MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP CR ARTIC SURF SZ3; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500563
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device finds the smaller balseal is damaged.Hhe (health hazard evaluation)/qrb (quality review board) (b)(4) recommended a device correction which was initiated on june 12, 2015.Capa-(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-(b)(4) will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor per post market surveillance (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
The two attune rp cr artic surf sz3 were reported for being broken.
Additional Manufacturer Narrative
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.Product complaint (b)(4).Investigation summary :examination of the returned device finds the smaller balseal is damaged.Hhe (health hazard evaluation)/qrb (quality review board) 103045639 recommended a device correction which was initiated on (b)(6) 2015.Capa-004795 determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-004795 will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor per post market surveillance sep-419.Capa-004795 determined the likely root cause to be related to misuse.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP CR ARTIC SURF SZ3
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8264009
• Report Number: 1818910-2019-81570
• Device Sequence Number: 13847541
• Product Code: JWH
• UDI-Device Identifier: 10603295133032
• UDI-Public: 10603295133032
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 12/28/2018

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: 254500563
• Device Lot Number: MVMCJX290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1