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

Catalog Number 71364073

Device Problem Break (1069)

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

Event Date 11/20/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, end of the reamer shaft broke off.Both pieces recovered.No delay.No confirmation of backup has been received.No impact or injury to patient reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The mi z handle acetabular reamer became non-functional due to the fracture of one of the clevis in the reamer shaft.The clevis most likely fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the clevis could not bear the imposed torsional loading, which lead to a fracture.Fatigue cracking is caused by the reamer bearing cyclic (i.E.Repeated) stresses in excess of the material endurance limit for an extended period of time.The broken pieces was not returned with the device.The device was manufactured in 2019.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 any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: MI Z HANDLE ACET REAMER
• Type of Device: PROSTHESIS,HIP,FEMORALCOMPONENT,CEMENTED,METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9480626
• MDR Text Key: 177354324
• Report Number: 1020279-2019-04420
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71364073
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1