MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISTAL FEMUR CUTTING BLOCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	74016205
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka, the distal femur cutting block second hole was found to have a relief cut that goes thru the pin hole, and cuts the pin.It is unknown how the procedure was finished or if this caused any delay.No patient harm reported.
Additional Manufacturer Narrative
Lot number added, manufacture date added.(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation.A visual inspection of the distal femur cutting block confirms the cutting holes are severely damaged.The cutting holes have burrs and gouges that would cause the stated failure.The device shows signs of significant wear and use.The contribution of the device to the reported event could not be corroborated.A review of complaint history revealed similar events for the listed 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.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 product and failure mode.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the distal femur cutting block confirms the cutting holes are severely damaged.The cutting holes have burrs and gouges that would cause the stated failure.The device shows signs of significant wear and use.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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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: DISTAL FEMUR CUTTING BLOCK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12250743
• Report Number: 1020279-2021-06112
• Device Sequence Number: 2772023
• Product Code: LXH
• UDI-Device Identifier: 00885556735213
• UDI-Public: 885556735213
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup,Followup
• Report Date (Section B): 01/06/2022

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 Catalogue Number: 74016205
• Device Lot Number: 19MSY0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 11/26/2021; 01/05/2022
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/22/2021; 11/30/2021; 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown