MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 5 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Catalog Number 254500735

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2018

Event Type  malfunction  

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 Description

Attune trial's balseal stretched and so requires replacement.In addition, a 5 left ps trial attune femur is broken and also requires replacement.Please ship on (b)(4).Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

(b)(4).Investigation summary examination of the returned finds the trial is cracked.The root cause is attributed to product wear out due to normal intended use.Dra-004111 was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor via sep-419.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned finds the trial is cracked.The root cause is attributed to product wear out due to normal intended use.(b)(4) was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM TRIAL SZ 5 LT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7654688
• MDR Text Key: 112870439
• Report Number: 1818910-2018-63621
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295134077
• UDI-Public: 10603295134077
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 254500735
• Device Lot Number: MVMCBH900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/12/2018; 07/13/2018
• Supplement Dates FDA Received: 07/20/2018; 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1