MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 5 X 38 SELFTAP CAN SCR TI; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71755038
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after implantation of a humeral nail implantation had been performed on (b)(6) 2020, the implant's proximal screw mobilised.A revision surgery took place on (b)(6) 2020 for the repositioning of the screw.The patient outcome is unknown.
Event or Problem Description
It was reported that due a mobilization of the implant's proximal screws that were implanted on (b)(6) 2020 a revision surgery took place on (b)(6) 2020 for the repositioning of the screws.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant clinical information was provided to confirm the reported mobilization nor revision.Per subsequent e-mail, it was reported the same implants were repositioned.Based on the information provided, the future impact to the patient beyond the reported revision cannot be determined.Since there was no reported harm or injury to this patient, no further clinical/medical assessment is warranted 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.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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: 5 X 38 SELFTAP CAN SCR TI
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10785158
• Report Number: 1020279-2020-06115
• Device Sequence Number: 3732348
• Product Code: HSB
• UDI-Device Identifier: 03596010500083
• UDI-Public: 03596010500083
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K032722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71755038
• Device Catalogue Number: 71755038
• Device Lot Number: 19EM15962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR