MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. MBT REVISION REAMER 12MM; KNEE INSTRUMENTS

Catalog Number 217863172

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/08/2016

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 instruments are stripped and are not in usable condition.

Manufacturer Narrative

Additional narrative: the device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.A search of the complaint database against the reported product code found additional reports of stripped/non-functional.The additional reports were investigated and attributed the root cause to device wear from normal use and servicing.The investigation could not draw any conclusions about the current reported damage without the device to examine.The reported problem is consistent with the mating attachment features becoming worn/stripped when the reamer becomes in contact with hard cortical bone.Based on the inability to determine a root cause, a need for corrective action is not indicated 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: MBT REVISION REAMER 12MM
• Type of Device: KNEE INSTRUMENTS
• 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: 6194196
• MDR Text Key: 62980587
• Report Number: 1818910-2016-33777
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Report Date: 12/08/2016

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: 217863172
• Device Lot Number: NG0709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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