MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC STD 265MM 11 CBL TRCH GRIP; CERCLAGE, FIXATION

Model Number	71340013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2019 due to implant breakage, a competitor stem was broken as well.
Additional Manufacturer Narrative
A2 correction.The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured in half and all pieces were returned.The device was manufactured in 2015.The medical investigation concluded that clinical documents or the radiographs were not provided.The photo of the broken implant, radiograph reports, operative report and the visual inspection all confirms the stated failure.Age related wear likely caused this reported event.The impact to this patient beyond a revision surgery cannot be determined.No further clinical/medical assessment is warranted at this time.The lab analysis of the returned device found the implant fractured at the wire/clamp connection.Scoring, gouging, and metal displacement was present near the fractured surface on the upper portion of the returned device.The damage was apparent in three additional areas on the bottom portion of the troch grip.It is not known if this type of damage occurred during the removal process or not.No evidence of deviation in processing or material was found for the retrieved items.No conclusions as to the cause of this issue can be determined.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely overloading of the device.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 is warranted for this complaint.

• Brand Name: ACC STD 265MM 11 CBL TRCH GRIP
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9440661
• Report Number: 1020279-2019-04339
• Device Sequence Number: 3282473
• Product Code: JDQ
• UDI-Device Identifier: 03596010485823
• UDI-Public: 03596010485823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71340013
• Device Catalogue Number: 71340013
• Device Lot Number: 15GSM0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR