MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 10 X 30; NAIL, FIXATION, BONE

Model Number	71653030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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
Results of investigation: the associated device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.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.Some potential probable causes for this event could include a procedural error or device wear.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: META RETRO FEM NAIL 10 X 30
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10122902
• Report Number: 1020279-2020-02004
• Device Sequence Number: 11475832
• Product Code: JDS
• UDI-Device Identifier: 03596010548160
• UDI-Public: 03596010548160
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K051557
• 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): 09/17/2020

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 Expiration Date: 11/23/2025
• Device Model Number: 71653030
• Device Catalogue Number: 71653030
• Device Lot Number: 15LSM0142
• Initial Date Received by Manufacturer: 05/09/2020
• Supplement Date Received by Manufacturer: 09/12/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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