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	Injury (2348)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a compass universal hinge was put on the patient and broke 4 weeks after the surgery.The broken piece was replaced with a smith and nephew device.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured at the connection point of the lateral hinge base.The gear sub-assembly was not returned with the device.The device had numerous nicks and scratches from use.The clinical / medical investigation concluded that, per complaint details, the device broke four weeks after implantation; however, the broken pieces were replaced with a smith and nephew backup device.Based on the limited information provided the root cause could not be definitively concluded.Since there were no patient injury or retained foreign body resulted per complaint; no further impact to the patient is anticipated.Therefore, no further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.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 material in use, a procedural error or a traumatic injury.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.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: 10356562
• Report Number: 1020279-2020-03639
• Device Sequence Number: 2399276
• Product Code: JDW
• UDI-Device Identifier: 03596010328212
• UDI-Public: 03596010328212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 71060001
• Device Catalogue Number: 71060001
• Device Lot Number: 19EM08409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 07/14/2021
• 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