MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT DISTAL REAMER 190MM SZ 13; PROSTHESSHIPSMICNSTRINDMETLCERMICPOLYMRCEMENTEDNOPORUSUNCMNTD

Model Number	OR71355344
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure, while reamer was inside the patient it stripped.No delay.Backup device available.No impact or injury to patient reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that after the investigation was performed and while reviewing the case, the stated failure mode presented, it can be confirmed that the patient had no injury, nor potential injury due to this malfunction, additionally a backup device was used to finish the surgery, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: REDAPT DISTAL REAMER 190MM SZ 13
• Common Device Name: PROSTHESSHIPSMICNSTRINDMETLCERMICPOLYMRCEMENTEDNOPORUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9398668
• Report Number: 1020279-2019-04246
• Device Sequence Number: 2701307
• Product Code: LZO
• UDI-Device Identifier: 00885556580929
• UDI-Public: 00885556580929
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OR71355344
• Device Catalogue Number: 71355344
• Device Lot Number: 16HUQ0014
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1