MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS 1818910 SP2 AP CHAMF BLK POPUP R.H.SZ4; KNEE INSTRUMENT/TRIAL

Catalog Number 966144

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The sigma 4 ap cutting block cracked at the chanfer saw capture.Block is broken and no longer usable in surgery.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: the product was received at depuy synthes.The appropriate fields have been updated.

Manufacturer Narrative

A worldwide complaint database search by the product code 966144 did not reveal any similar complaints.The device was evaluated by material scientists per (b)(4).The component was fractured due to high stress low cycle bending fatigue crack initiation and propagation.Fracture initiations from the distal surface on both anterior and posterior aspects of the fracture surface were consistent with the use of both cutting slots.The component was cyclically loaded beyond the material endurance limit, resulting in fatigue crack initiation and propagation.No material defects were observed in the component that could have contributed to fracture initiation and/or propagation to failure.The root cause is being contributed to misuse by cyclically loading beyond the material endurance limit.Continue to monitor per (b)(4).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.

• Brand Name: SP2 AP CHAMF BLK POPUP R.H.SZ4
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6249301
• MDR Text Key: 64759295
• Report Number: 1818910-2017-10835
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 966144
• Device Lot Number: GM0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1