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

Catalog Number 71060001

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 06/25/2020

Event Type  Injury  

Event Description

It was reported that (b)(6) female having application of compass knee hinge for fracture and multiple ligament damage.Initial stabilizing ex-fix (hoffmann) removed in theatre, compass hinge and frame were applied by surgeons as per surgical technique.Surgeon tightened bolts/nuts at completion of procedure, the hinge snapped when set screw (valgus/varus adjustment) on slave hinge was being tightened.Replacement hinge required to replace this slave hinge as valgus/varus adjustment is unable to be locked in place.Hinge stabilized with threaded rods until replacement arrives.

Manufacturer Narrative

The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.According to clinical/medical investigation, a replacement device was not readily available, therefore the hinge stabilized with threaded rods and the patient was brought to the post-op ward, until the replacement arrives from the warehouse.It was further communicated via email that the additional requested information and patient outcome is not available, due to no consent being provided.Therefore, no further assessment can be provided at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: COMPASS UNIVERSAL HINGE
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10279062
• MDR Text Key: 199043927
• Report Number: 1020279-2020-03222
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71060001
• Device Lot Number: 20CM02722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR