MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US FEMORAL/HUMERAL HEAD IMPACTOR; EXTREMITY INSTRUMENTS : IMPACTORS

Catalog Number 200165000

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned device finds the impactor is damaged.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Several worn/broken instruments.Please ship on (b)(6).Attune femoral impactor has cement that cannot be removed.36 trial head is very scratched up.Attune trial is missing a bal seal attune shim is broken in half.Attune saw capture, a piece of the red button broke.Femoral head impactor, it's simply very worn out.Patient consequence? : no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: FEMORAL/HUMERAL HEAD IMPACTOR
• Type of Device: EXTREMITY INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7914222
• MDR Text Key: 122006180
• Report Number: 1818910-2018-70686
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295080121
• UDI-Public: 10603295080121
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 200165000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1