MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCRW-N R3 0DEG 36MM TRL ACET LNR 54MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	71935664
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the surgeon was screwing the scrw-n r3 0deg 36mm trl acet lnr 54mm into 54r cup and the screw broke through the trial liner.All pieces were found.No delay to procedure.No backup was needed, surgeon just inserted the implant instead of the trial.No patient injury and patient is doing fine.No further complications were reported at this time.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection confirmed the screw is broken off the scrw-n r3 0deg 36mm trl acet lnr 54mm.The device shows significant signs of wear/usage.The clinical/medical evaluation concluded that per complaint details, the device broke during trailing; however, all pieces were found.Reportedly the surgeon ¿just inserted the (final) implant instead of the trial¿ / did not require a trial backup.It was communicated that there was no surgical delay, the patient is ¿doing fine¿, and no patient injury resulted.The product evaluation will be performed independent of this medical investigation.Patient impact beyond the modified surgical procedure would not be anticipated as the procedure was reportedly completed with the same device and the final implant was implanted without retained foreign bodies, patient harm, and/or surgical delay.Since no patient injury/harm was alleged, no further medical assessment is warranted at this time.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.We consider this investigation closed.

• Brand Name: SCRW-N R3 0DEG 36MM TRL ACET LNR 54MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326544
• Report Number: 1020279-2021-01293
• Device Sequence Number: 837982
• Product Code: JDH
• UDI-Device Identifier: 00885556723456
• UDI-Public: 885556723456
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 07/21/2021

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 Catalogue Number: 71935664
• Device Lot Number: E8915-5-032210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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