MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL

Catalog Number 71364073

Device Problem Mechanical Jam (2983)

Patient Problems Laceration(s) (1946); Tissue Breakdown (2681)

Event Date 12/23/2020

Event Type  Injury  

Event Description

It was reported that, during an anterior left tha performed on (b)(6) 2020, a 58mm reamer failed and sized up.The failure caused dramatic external rotation of the reaming device, leading to eccentric reaming of the socket rather than concentric reaming and causing injuries to the patient.No back-up instrument was available at the moment due non-functioning autoclave machine, and the staff was forced to use straight 66mm reamer, causing the capsule to be mispositioned.No other complications were reported.

Manufacturer Narrative

D1: brand name added.D4: expiration date and udi added.H4: manufacture date added.(b)(4).D4: catalog number and lot number updated.

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 confirmed by a visual inspection.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.Only the inner portion of the device was returned.None of the other pieces of the device was returned for evaluation.A lab analysis confirms as received components shown in attached photos depicts two segments of the acetabular reamer.Attached photos in report show the fractured surface of the pin geometry of the distal section of the acetabular reamer.The electron microscope images of the fracture surface are in the attached photos in the report.The pin housing failure could have been due to repeated cyclic high load initiating crack and over time fracturing.The edx (energy dispersive x-ray spectroscopy) report generated from the fracture surface indicates the device was manufactured according to the internal specification and the device failure could have been initiated by repeated overloading the device beyond its design strength of the material.A medical investigation was conducted and confirms it was reported during an anterior left tha performed on 23-dec-2020, a 58mm reamer failed and sized up.The failure caused dramatic external rotation of the reaming device, leading to eccentric reaming of the socket rather than concentric reaming and causing injuries to the patient.No back-up instrument was available at the moment due non-functioning autoclave machine, and the staff was forced to use straight 66mm reamer, causing the capsule to be mispositioned.The operative report was not provided.The patient had a revision 27 days post implantation and it is noted the device is not available for return.Conclusion: without the operative report and return of the device, the root cause of the reported event could not be definitively concluded, although a user/procedural variance could not be ruled out as a potential contributing factor to the reported eccentric reaming.It is the o.R.Staff and surgeon responsibility to ensure that back-up instruments are available prior to the surgical procedure.The patient impact beyond the reported eccentric reaming of the socket and subsequent revision cannot be determined.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 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 Z HANDLE ACET REAMER
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11821887
• MDR Text Key: 250589155
• Report Number: 1020279-2021-04270
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71364073
• Device Lot Number: 16FM06374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention