MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COMPASS UNIVERSAL HINGE; PIN, FIXATION, THREADED

Model Number	71060001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after an external fixation surgery, the t-bolt from a compass universal hinge broke.This event was solved by a replacement sent to the patient on (b)(6) 2021.Patient was not injured as consequence of this problem.
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 has damage along one of the slots that mates with the t-bolt which was likely from use of the device.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.Damage from misuse or rough handling are likely probable causes of the reported event.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: COMPASS UNIVERSAL HINGE
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12332000
• Report Number: 1020279-2021-06417
• Device Sequence Number: 19534639
• Product Code: JDW
• UDI-Device Identifier: 03596010328212
• UDI-Public: 03596010328212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 71060001
• Device Catalogue Number: 71060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1