MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF TRIAL SHELL HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71362297
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, while impacting the trial cup in, one of the threads broke loose.This caused the impactor to not grab the trial cup well.The impactor was discontinued and a sn back up was used in order to complete the procedure.No pieces fell into the patient.All pieces were recovered and the broken piece was discarded.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Per photos attached to complaint, device was not received by complaints department.The packaging has a whole on the side where the device potentially fell out from.A medical investigation was conducted and confirms per complaint details, the device broke during the procedure/¿thread broke loose¿; however a s +n backup was available and used to complete the procedure without report of patient injury or surgical delay.Per correspondence, the instrument broke outside of the patient, no pieces fell into the patient, and all pieces were recovered.It was communicated no patient information was available.Reportedly, there was no surgical delay or patient injury alleged and since no fragments fell into the wound/all pieces were recovered and the procedure was successfully completed with a backup device, the assessed patient impact was limited to the use of the available backup device.Based on this information, no further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 repeated use can occur.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.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: REF TRIAL SHELL HANDLE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11648441
• Report Number: 1020279-2021-02919
• Device Sequence Number: 11602031
• Product Code: JDI
• UDI-Device Identifier: 03596010456540
• UDI-Public: 03596010456540
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• 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): 07/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71362297
• Device Catalogue Number: 71362297
• Device Lot Number: 17KTA0003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: Hospitalization; Other; Required Intervention