MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIV REV FEM BROACH 31MM; KNEE INSTRUMENT : BROACHES

Model Number	96-1683
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the femur cracked while broaching with 31 broach, prepping the femur for a tc3/31 sleeve/ 14 mm stem.Surgical delay of 10 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: corrected: h6 (patient).Removed not applicable code and replaced with no code available (3191) to capture prolonged surgery and insufficient information.

• Brand Name: UNIV REV FEM BROACH 31MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10252268
• Report Number: 1818910-2020-15417
• Device Sequence Number: 13574353
• Product Code: HTQ
• UDI-Device Identifier: 10603295239819
• UDI-Public: 10603295239819
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96-1683
• Device Catalogue Number: 961683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention