MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRIMARY ACETABULAR REAMER INSTR SET; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71360290

Device Problem Dull, Blunt (2407)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/21/2021

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, two primary acetabular reamer instr sets were blunt.Surgery was resumed, with a competitors (stryker) back-up device.Surgeon stated that due to the reamers being so blunt and excessive pushing, the back wall of the acetabulum was penetrated and would require bone graft to repair adding a further 30mins to the procedure.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, there is a penetration of the acetabulum due to blunt acetabular reamers, ¿causing excessive pushing,¿ which ¿would require bone graft to repair adding a further 30 minutes to the procedure.¿ it was communicated via email, ¿we don¿t have the patient details and medical history in this case.¿ no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, no further clinical assessment can be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A complaint history review found related failures for the listed devices; 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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: PRIMARY ACETABULAR REAMER INSTR SET
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12471434
• MDR Text Key: 271440299
• Report Number: 1020279-2021-06834
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71360290
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention