MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 34CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675509
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up or inspection of a trauma surgery, it was noticed that the sealed packaging of the inner wrapper of an intertan 10s 10mm x 34cm 125d left was disassociated with the plastic, leaving a spot that compromised sterility.Since the wrapper was not attached any longer to the plastic there was a hole where air could move in and out.This was noticed prior to the scrub tech touching or receiving the implant.The procedure was successfully completed without delay using a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device, was not returned for evaluation and the failure mode could not be confirmed.A review of complaint history did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An historical review concluded that there are no prior actions related to this product and event.A review of the packaging inspection procedure was conducted, and it revealed the inner wrapper should be sealed.The contribution of the device to the reported event could not be corroborated.At this time, we do not have evidence to suspect that the product failed to meet product specifications at the time of manufacture.Manufacturing process errors or mishandling could be probable causes of the reported event.This issue was evaluated through our internal quality process and determined to be isolated at this time.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.

• Brand Name: INTERTAN 10S 10MM X 34CM 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: 11810796
• Report Number: 1020279-2021-04071
• Device Sequence Number: 14400996
• Product Code: JDS
• UDI-Device Identifier: 00885556344149
• UDI-Public: 00885556344149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 71675509
• Device Catalogue Number: 71675509
• Device Lot Number: 20KM12653
• 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: 04/21/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2020
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown