MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI CONV TRL +8MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71367908
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during total hip replacement the unipolar trial heads do not stay on the stem or broach trials.It was tried all 5 devices and the pop off non stop.A delay was reported of 10 minutes to 15 minutes.The procedure was finished using a change in the surgical technique.A different device has to be used to finished the procedure.The procedure was finished using 28 mm bipolar head.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.Visual inspection of the returned device confirms that the device has signs of wear and tear at the rim from use which is why it does not stay in place.The clinical/medical evaluation concluded that the unipolar trial heads would not stay on the stem or broach trials.Reportedly, ¿the patient is fine, the procedure was finished using a change in the surgical technique¿.A different device had to be used to finished the procedure.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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 investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: TANDEM UNI CONV TRL +8MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293440
• Report Number: 1020279-2020-03322
• Device Sequence Number: 19035329
• Product Code: LXH
• UDI-Device Identifier: 03596010481764
• UDI-Public: 03596010481764
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 71367908
• Device Catalogue Number: 71367908
• Device Lot Number: 13AM14772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 08/06/2021
• 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