MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX CAP SCR 5.0MM X 35MM; NAIL, FIXATION, BONE

Catalog Number	71642235
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery to remove trigen retrograde femoral nail (initial insertion date (b)(6) 2019, revision surgery date (b)(6) 2020) the threads of the 2 proximal internal hex capture screws disassembled during removal and furthermore fell into the medullary canal.The surgeon had a hard time to remove them and the surgery was delayed by more than 30 mins.There was no impact on the patient.
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 threads on the device are heavily damaged and partially removed.A shard of metal from the threads was returned with the device.The medical investigation concluded that, based on the limited information provided, the root cause of the reported issue cannot be determined.Although a surgical delay was reported per e-mail communication, there was no impact on the patient and it was noted that the ¿patient is fine.¿ no further clinical assessment is warranted at this time.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 do not have 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 a procedural error or device wear.Based on this investigation, the need for corrective action is not 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.

• Brand Name: INT HEX CAP SCR 5.0MM X 35MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10122876
• Report Number: 1020279-2020-02003
• Device Sequence Number: 11475831
• Product Code: JDS
• UDI-Device Identifier: 03596010464996
• UDI-Public: 3596010464996
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 71642235
• Device Lot Number: 18AM05805
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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: 35 YR