MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT DISTAL REAMER 190MM SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC

Model Number	71355344
Medical Device Problem Codes	Defective Device (2588); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon reamed femoral canal with the redapt 13x190 distal reamer.When the time came to remove, the reamer would not stay connected to the adaptor.There was a delay of roughly 45 minutes as surgeon tried to retrieve the reamer from the patient.Once removed from the patient and after inspection, the proximal end of the reamer was found to be bent.No backup s&n instrument was available and procedure was completed with the same device.No patient injury occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the surgeon reamed femoral canal with the redapt 13x190 distal reamer.When the time came to remove, the reamer would not stay connected to the adaptor.There was a delay of roughly 45 minutes as surgeon tried to retrieve the reamer from the patient using vice grips and mallet.Once removed from the patient and after inspection, the proximal end of the reamer was found to be bent.No backup s&n instrument was available and procedure was completed with the same device following standard operation technique.No patient injury occurred.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that upon removal, the reamer would not stay connected to the adaptor.Per email communication, the reamer was retrieved using vice grips and a mallet, and no patient harm or injury.The procedure was completed following standard operating technique, with approximately a 45-minute delay.No further clinical assessment is warranted.A review of complaint history did not reveal additional complaints for the listed batch.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 product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.Based on the alleged failure and the date when the product was manufactured, a further review of the manufacturing records was not deemed necessary.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 device 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.We consider this investigation closed.

• Brand Name: REDAPT DISTAL REAMER 190MM SZ 13
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10632326
• Report Number: 1020279-2020-05164
• Device Sequence Number: 3003951
• Product Code: MEH
• UDI-Device Identifier: 00885556580929
• UDI-Public: 00885556580929
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• 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,Followup
• Report Date (Section B): 10/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71355344
• Device Catalogue Number: 71355344
• Device Lot Number: 16AUO0017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/15/2021
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/08/2020; 10/18/2021
• 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: Required Intervention