MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB 2 DEG BROACH 37MM; KNEE INSTRUMENT : BROACHES

Catalog Number	217863111
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During surgery the tibial femoral sleeve clamp repeatedly locked open in certain positions, and needed to be shaken in order to get it to function again.The 2 deg broach 37 mm would not accept any of the stem trials (75 x 12mm specifically).The stem trial would not fit far enough into the broach for the tabs to lock into their assigned slots.The stem sat to proud a couple of mm and wouldn't seat properly, as if something was in the hole it was meant to sit in.Upon examination nothing could be seen that would cause this issue.Action taken to manage the problem during surgery: persistent attempts to get the clamp to function as designed, shaking, jiggling, inverting.Surgeon moved to the next size broach (45mm).2 minute delay to the procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch ,a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REV TIB 2 DEG BROACH 37MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8070280
• Report Number: 1818910-2018-75462
• Device Sequence Number: 19380824
• Product Code: HTQ
• UDI-Device Identifier: 10603295096085
• UDI-Public: 10603295096085
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 217863111
• Device Lot Number: A0305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1