MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 32 +4; PRSTHSS,KNEE,PTLLO/FMRTBL,SM-CNSTRNED,UNCMNTD,PROUS,COATED,PLMER/METAL/PLMER

Catalog Number	71369716
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, a tab in the trial head snapped off, and it would not stay on the stem.There were no delays in the procedure and a backup device was available.No patient injuries reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection of the returned device confirms the trial fem head tab is broken and the piece was not returned.The manufacture date is unknown for this device.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: MI TRIAL FEM HEAD 32 +4
• Common Device Name: PRSTHSS,KNEE,PTLLO/FMRTBL,SM-CNSTRNED,UNCMNTD,PROUS,COATED,PLMER/METAL/PLMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9390629
• Report Number: 1020279-2019-04196
• Device Sequence Number: 3067305
• Product Code: MBH
• UDI-Device Identifier: 03596010555625
• UDI-Public: 03596010555625
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 71369716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1