MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DOUBLE OFFSET BROACH HANDLE LEFT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71935641
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure and outside the patient it was discovered that it was too hard to open and close the double offset broach handle.No injuries or surgical delays reported.Surgery was finished with an s+n backup device.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned broach handle does not show any obvious signs of damage.There is no lot number available for this device.The device exhibits signs of normal wear and use.The stated failure was confirmed with a functional evaluation.A broach was connected to the broach handle and it¿s very tight.The handle should open and close with ease.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: DOUBLE OFFSET BROACH HANDLE LEFT
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10681026
• Report Number: 1020279-2020-05376
• Device Sequence Number: 16891882
• Product Code: JDG
• UDI-Device Identifier: 00885556717417
• UDI-Public: 885556717417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/23/2020

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 Catalogue Number: 71935641
• Device Lot Number: E0014106-1-080714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1