MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 11.0MM PILOT NOSE IRH; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71118236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the edge of the blades broke after the reamer hit the k-wire.The surgeon used a 2.4 mm k-wire to block during reaming.No delay reported.No patient injuries reported.An s&n backup was available.
Additional Manufacturer Narrative
The device, used in treatment, were returned for evaluation.A visual inspection confirmed the pilot nose reamer has nicks and burrs.Also the pilot nose reamer is dull.This device shows significant signs of wear/usage.The date of manufacture is unknown for this device.A medical investigation was conducted and this case reports that the edge of the blades broke after the reamer hit the k-wire.Per complaint details, all the pieces were removed, and there was no injury or delay.The procedure was completed using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: 11.0MM PILOT NOSE IRH
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10702610
• Report Number: 1020279-2020-05556
• Device Sequence Number: 3630295
• Product Code: JDG
• UDI-Device Identifier: 03596010409447
• UDI-Public: 03596010409447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71118236
• Device Catalogue Number: 71118236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PILOT NOSE IRH 71118238, LOT UNKNOWN; PILOT NOSE IRH 71118238, LOT UNKNOWN