MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF TRIAL SHELL HANDLE; PROSTHESIS,HIP,FEMORALCOMPONENT,CEMENTED,METAL

Model Number	71362297
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the reflection trial shell handle tears off the thread when the trial cup was inserted, furthermore a metal ring of the broken thread was found in the patient operating field and was completely removed under bv; in addition, after the thread was torn off, the metallic sharply broken off partial thread stuck out of the test cup, tearing the gloves of the surgeon and the operating nurse; the procedure was successfully completed without delay using the same device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is cracked, damaged and has signs of wear and tear from use.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.A complaint history review for the listed batch revealed no prior complaints for the failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.A review of risk management file found that the reported failure was documented appropriately.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.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.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.G1.

• Brand Name: REF TRIAL SHELL HANDLE
• Common Device Name: PROSTHESIS,HIP,FEMORALCOMPONENT,CEMENTED,METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10457862
• Report Number: 1020279-2020-04238
• Device Sequence Number: 14187692
• Product Code: JDG
• UDI-Device Identifier: 03596010456540
• UDI-Public: 03596010456540
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71362297
• Device Catalogue Number: 71362297
• Device Lot Number: 16MTA0024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 05/16/2021
• 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