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 Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The attune pin jack broke.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Examination of the returned device confirms the reported event of breakage.The received 254500060 attune pin puller was forwarded to depuy material science for review.On the basis of these observations, the fracture of the pin grasper of the pin jack was caused by ductile overload, indicative of a bending force applied with the handle with respect to an engaged pin exceeding the ultimate strength of the material.Based on the root cause of overload corrective action is not indicated.Continue to monitor via (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: 5633581
• MDR Text Key: 44465897
• Report Number: 1818910-2016-18652
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2016

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: PG231419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2016; 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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
• Patient Weight: 108