MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROXIMAL REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71364015
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during total hip replacement inside the patient it was noticed that the proximal reamer being dull.No delay reported.The procedure was finished using a changed in surgical technique.It was used a synergy reamer and a synergy broach to lateralize as the proximal reamer was dull.The surgical procedure was completed satisfactorily.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the proximal reamer confirms the device is dull.This device was manufactured in 2014.This device shows signs of significant wear/usage.A medical investigation was conducted and this case reports that during the surgery, the proximal reamer was noticed to be dull.Per email communication, the procedure was successfully completed with a change in surgical technique, using a synergy reamer and a synergy broach was used to lateralize.There is no patient injury or delay reported.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.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 risk management files found that the reported failure was documented appropriately.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.

• Brand Name: PROXIMAL REAMER
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10457921
• Report Number: 1020279-2020-04242
• Device Sequence Number: 2939092
• Product Code: JDG
• UDI-Device Identifier: 03596010384065
• UDI-Public: 03596010384065
• Combination Product (Y/N): N
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71364015
• Device Catalogue Number: 71364015
• Device Lot Number: 14BM21234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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