MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADOLESCENT TAN 8.5X38L; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71645138
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an adolescent tan 8.5x38l and a 4.5 lp screw had to be removed from the patient.After initial surgery the patient felt pain and went to the clinic to get it looked at.The nail was bent and the screw broke while inside the patient.Another tan nail and screw were implanted.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is severely bent and has signs of damage from implantation / extraction.The clinical medical investigation concluded that the responses to clinical requests were not provided, therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported pain nor breakages.The four undated/unlabeled photos confirmed the reported breakages.Based on the information provided another tan nail and screw were implanted.The patient impact beyond the reported event could not be determined based on the limited information provided.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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.Some potential probable causes for this event could include surgical technique or a traumatic injury.Based on this investigation, the need for corrective action is indicated.Should 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: ADOLESCENT TAN 8.5X38L
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10701895
• Report Number: 1020279-2020-05538
• Device Sequence Number: 3933854
• Product Code: HSB
• UDI-Device Identifier: 03596010541345
• UDI-Public: 03596010541345
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 71645138
• Device Catalogue Number: 71645138
• Device Lot Number: 16MT79945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 LP SCREW
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention