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

Catalog Number 254500060

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this 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

The pin jack did not remove the drill pins effectively.It didn't appear to grip onto the pins and was damaging the surface of them, creating metal shards.

Manufacturer Narrative

Device available for evaluation this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination and functional testing of the returned device was unable to confirm the reported event.The returned pin puller was functionally tested with a depuy retained pin and found the grab, hold and secure the pin as intended.The investigation could not verify or identify any product contribution to the reported event with the information provided as the returned device functioned as intended.Based on the inability to identify root cause, the need for corrective action was not indicated.Continue to monitor via sep-419.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: 5434185
• MDR Text Key: 38135246
• Report Number: 1818910-2016-13204
• 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,Followup
• Report Date: 02/11/2016

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: PG246429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2016; 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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