MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV.TRIAL HEAD 36 MM 12/14 +0; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	76544151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown procedure, the surgeon was attempting to trial the head and it would not attach to the trial neck.It was found that the inner portion of the trial head was broken.The client believes that it happened during sterilization, not during surgery.S&n backup device available.Surgical delay of less than or equal to 30 minutes.Patient was not harmed.
Additional Manufacturer Narrative
Results of investigation:the device, used in treatment, was not returned for evaluation.Per photo attached to the complaint, the device is severely damaged.Also the connections tabs seem to be cracked.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNIV.TRIAL HEAD 36 MM 12/14 +0
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10773147
• Report Number: 1020279-2020-06009
• Device Sequence Number: 11670007
• Product Code: LXH
• UDI-Device Identifier: 03596010543424
• UDI-Public: 03596010543424
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Model Number: 76544151
• Device Catalogue Number: 76544151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1