MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI OFFSET REF IMP SD SHAFT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71364023
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 a thr the following instruments broke.Instruments inside patient.Unknown how the procedure was finished or if there was a surgical delay.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirmed the hex tip is stripped causing stated failure.The device was manufactured in 2017.The device show significant signs of wear/usage.A medical investigation was conducted and confirms this case reports the offset positioner/impactor broke during use.It is unknown whether the broken piece fell inside the patient, and there has been no response to the documentation/information requests.It is also unknown how the procedure was completed.There was no patient injury, delay or other complications reported.Therefore, since no patient harm is alleged, no further clinical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch number 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.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: MI OFFSET REF IMP SD SHAFT
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326451
• Report Number: 1020279-2021-01279
• Device Sequence Number: 16341852
• Product Code: JDG
• UDI-Device Identifier: 03596010479136
• UDI-Public: 03596010479136
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71364023
• Device Catalogue Number: 71364023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/16/2021
• 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: Hospitalization; Other; Required Intervention