MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 36CM 130D LEFT; NAIL, FIXATION, BONE

Catalog Number	71675512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient came in to the hospital with a broken nail.
Additional Manufacturer Narrative
The associated intertan nail was not returned for evaluation.A clinical investigation noted that no clinical relevant information has been provided to conduct a thorough analysis of the reported issue.A medical assessment is warranted at this time.Our investigation included a review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no prior complaints for this failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 10S 10MM X 36CM 130D LEFT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7295509
• Report Number: 1020279-2018-00239
• Device Sequence Number: 13756124
• Product Code: JDS
• UDI-Device Identifier: 00885556344293
• UDI-Public: 00885556344293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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 Catalogue Number: 71675512
• Device Lot Number: 15HM21439
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention