MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE PIN PULLER; KNEE INSTRUMENT/TRIAL

Catalog Number 254500060

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: this complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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

During total knee arthroplasty there were scratches on the pin when surgeon used pinjack to removed pin out of the bone.During removal procedure metal debris occurred and dropped into joint.The surgeon flushed metal debris out of patient.There was no adverse event on patient.

Manufacturer Narrative

The reported attune pin puller was not returned for evaluation.The root cause is attributed to suspected misuse/misapplication of the attune pin puller causing the generation of metal debris.Based on the root cause of suspected misuse, corrective action is not indicated.Continue to monitor via sep-(b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE PIN PULLER
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6139142
• MDR Text Key: 61248223
• Report Number: 1818910-2016-32652
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

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: 254500060
• Device Lot Number: PG246436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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