MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTI ROTATION BAR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71674041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery the anti rotation bar broke in half as the surgeon was inserting it into patient during hip fracture intertan case.The procedure had a delay of 5 minute.The procedure was finished using a smith and nephew backup device.No patient injury reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, although, it was reported the anti rotation bar broke in half as the surgeon was inserting it into patient during a hip fracture intertan case, it was reported the broken pieces were retrieve with a kocher clamp.Per the complaint details, the patient has a successful surgeon using a smith and nephew device with a reported 5-minute delay.Since all the pieces were removed and no other complications have been reported, no further clinical/medical assessment is warranted at this time.A visual inspection confirmed a piece of the bumber is broken off the journey fem impl impactor and has not been returned.The device shows significant signs of wear/usage.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 complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTI ROTATION BAR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10891310
• Report Number: 1020279-2020-06674
• Device Sequence Number: 14274032
• Product Code: HSB
• UDI-Device Identifier: 03596010605238
• UDI-Public: 03596010605238
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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): 02/22/2021

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: 71674041
• Device Catalogue Number: 71674041
• Device Lot Number: 17BSP0004
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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; Required Intervention