MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TIB 2 DEG BROACH 61MM; KNEE INSTRUMENT/TRIAL

Catalog Number 217863117

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 02/02/2017

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).

Event Description

Tibial rods would not insert into the mbt broach.

Manufacturer Narrative

Functional testing of the submitted mbt rev tib 2 deg broache with a retained tibial rod trial found the instruments would not assemble.Broaches utilize o-ring seal (b)(4), which controls the amount of force needed to insert the mating component into the broach.The vendor (tecomet) was contacted and supplied new o-rings for examination.The new o-rings allowed the broach to connect to the mating compent with the appropriate force.The new o-rings were also orange in color and softer than the black o-rings in the complaint products.However, all o-rings should meet the print specification of shore a hardness 50 (durometer specification).A complaint database search against the 217863xxx mbt rev tibial broach family group found additional reports of difficulties of assembly to broaches.The search identified complaints for this failure mode were manufactured in 2004 and 2005.The search did not identify any reports of assembly problems for 217863xxx mbt rev tibial broaches manufactured after 2005.No corrective action is being pursued at this time based on no reported patient harms and the low frequency of reported events.Monitor for complaints with product manufactured after 2005.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 REV TIB 2 DEG BROACH 61MM
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6352300
• MDR Text Key: 68096330
• Report Number: 1818910-2017-13194
• Device Sequence Number: 1
• Product Code: HTW
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217863117
• Device Lot Number: A1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2004
• 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