MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71364073

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2020

Event Type  Injury  

Event Description

It was reported that during a thr procedure the mi z handle acet reamer broke inside of the patient.Delays no longer than 30 min was reported.Surgery was finished with a s+n backup device.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports the reamer handle during use.Per email communication, the reamer shaft was in the reamer handle sleeve, and most of the reamer handle was outside the patient when used.There was no patient injury and a surgical delay of less than 30-minutes.The procedure was completed with a backup device.No further clinical assessment is warranted.A visual inspection confirmed the clevis of the mi z handle acet reamer is broken into two pieces.The device shows significant signs of wear/usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.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: MI Z HANDLE ACET REAMER
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10841644
• MDR Text Key: 216300972
• Report Number: 1020279-2020-06459
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010507570
• UDI-Public: 03596010507570
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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?: No
• Device Operator: Health Professional
• Device Model Number: 71364073
• Device Catalogue Number: 71364073
• Device Lot Number: 19GM25020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/15/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1