MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ALL POLY TIB IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71440196
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that impactor cracked when it was sterilized.No case involved.
Additional Manufacturer Narrative
Corrected data: d4.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Results of investigation: the device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has signs of wear and tear from use.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.

• Brand Name: GII ALL POLY TIB IMPACTOR
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10651052
• Report Number: 1020279-2020-05256
• Device Sequence Number: 2727302
• Product Code: JDG
• UDI-Device Identifier: 03596010214409
• UDI-Public: 03596010214409
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2020

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 Expiration Date: 06/21/2006
• Device Model Number: 71440196
• Device Catalogue Number: 71440196
• Device Lot Number: 60602049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/13/2020; 11/15/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 10/19/2020; 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1