MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI CONV TRL -3MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71367903
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Failure of Implant (1924); 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
H3, h6: the devices used in treatment were returned for evaluation.Visual inspection of the returned devices confirms that the devices has wear and tear from use.Functional testing of the returned devices confirms that because of wear and tear the devices pop off from stem and wouldn't stay in place.These devices were manufactured in 2013.According to clinical/medical investigation, this complaint from the united states reports 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 the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed parts revealed no prior complaints.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The devices are reusable device that can be exposed to numerous surgeries and cleaning cycles.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.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.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.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.

• Brand Name: TANDEM UNI CONV TRL -3MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293445
• Report Number: 1020279-2020-03325
• Device Sequence Number: 811144
• Product Code: LXH
• UDI-Device Identifier: 03596010481740
• UDI-Public: 03596010481740
• 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): 03/11/2021

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: 71367903
• Device Catalogue Number: 71367903
• Device Lot Number: 13AM04048
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 03/11/2021
• 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