MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX38CM 125D RT; NAIL, FIXATION, BONE

Model Number	71676558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery due to cut out.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical analysis indicated that based on the complaint details and provided image, non-union of the recently reduced/fixated im nailing was likely the contributing factor the reported event.The patient impact beyond the reported revision cannot be determined.No further medical assessment can be rendered at this time.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 complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.A review of the risk management file and instructions of use for the product was completed.Factors and/or some potential probable causes that could include but not limited to as overuse or excessive pressure on the joint, injury, non-union, improper technique and/or patient condition.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation 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.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 11.5MMX38CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8955462
• Report Number: 1020279-2019-03244
• Device Sequence Number: 2099980
• Product Code: JDS
• UDI-Device Identifier: 00885556039311
• UDI-Public: 00885556039311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Expiration Date: 09/10/2023
• Device Model Number: 71676558
• Device Catalogue Number: 71676558
• Device Lot Number: 13JT34493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR