MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 26CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675501
Medical Device Problem Codes	Defective Device (2588); Packaging Problem (3007)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, it was found the inner package of the intertan 10s 10mm x 26cm 125d left was expanding.After opening, tried to pick up with having "here" tab, but it didn't move.It was also found the plastic package was deformed.No harm to patient.No delay.It is unknown if there was a s&n back up to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same part number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage during shipping or mishandling or excessive exposure to high environmental temperatures could be probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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.

• Brand Name: INTERTAN 10S 10MM X 26CM 125D LEFT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10492283
• Report Number: 1020279-2020-04388
• Device Sequence Number: 2828206
• Product Code: JDS
• UDI-Device Identifier: 00885556343746
• UDI-Public: 00885556343746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Model Number: 71675501
• Device Catalogue Number: 71675501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown