MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST FX STRUT FOR TSF MED; PIN, FIXATION, THREADED

Model Number	71070720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, the shoulder bolts of a fast fx strut for tsf med and fast fx strut for tsf sht were tightened by hand and could then only be released with a wrench.Both threads were broken as a result.The shoulder bolt on the fast fx strut for tsf med even broke off.It is unknown whether the event happened during surgery and if there was patient involvement.
Additional Manufacturer Narrative
(b)(4).Correction to the event description.
Event or Problem Description
It was reported that, during an external fixation, the shoulder bolts of a fast fx strut for tsf med and fast fx strut for tsf sht were tightened by hand and could then only be released with a wrench.Both threads were broken as a result.The shoulder bolt on the fast fx strut for tsf med even broke off.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's thread components were damaged which prevented the device from tightening again.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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.The manufacturing process of the device did not contribute to the reported event.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Some potential probable causes could be but are not limited to user error or excessive loading on device.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FAST FX STRUT FOR TSF MED
• Common Device Name: PIN, FIXATION, THREADED
• 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: 12874512
• Report Number: 1020279-2021-08389
• Device Sequence Number: 14612194
• Product Code: JDW
• UDI-Device Identifier: 03596010443892
• UDI-Public: 03596010443892
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2022

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: 71070720
• Device Catalogue Number: 71070720
• Device Lot Number: 19LSM0183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021; 01/25/2022
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 11/29/2021; 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 71070710, FAST FX STRUT, LOT: 19LSM0196.
• Patient Sex: Unknown