MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEM LUG PUNCH; PROSTHESISKNEPATELOFEMOROTBIALSEMCNSTRAINDUNCMNTDPOROUSCOATDPOLYMERMTALPOLYMER

Catalog Number	71440183
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, instrument broke above the incision.No pieces fell into the patient and no injury reported, no delay and procedure was concluded with a backup device from smith and nephew.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned femoral lug punch indicated that short stepped lug punch busing has seized up on the short stepped lug punch, due to deformation/ mushrooming of the punch against the bushing.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 complaint history for the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII FEM LUG PUNCH
• Common Device Name: PROSTHESISKNEPATELOFEMOROTBIALSEMCNSTRAINDUNCMNTDPOROUSCOATDPOLYMERMTALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8597356
• Report Number: 1020279-2019-01834
• Device Sequence Number: 13998206
• Product Code: MBH
• UDI-Device Identifier: 03596010329868
• UDI-Public: 03596010329868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 71440183
• Device Lot Number: 09DM21615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1