MAUDE Adverse Event Report: DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655 PFC 3INHDLES STEINMN PIN PKG10; KNEE INSTRUMENT/TRIAL

Catalog Number 869117

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

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

Manufacturer Narrative

The received (b)(4) (product code (b)(4) were forwarded to commercialized product development 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 (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: PFC 3INHDLES STEINMN PIN PKG10
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6139160
• MDR Text Key: 61250349
• Report Number: 1818910-2016-32655
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

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: 869117
• Device Lot Number: 633194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• 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; Not provided
• Supplement Dates FDA Received: 12/15/2016; 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1