MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440822
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during tka, after doing the distal femoral cuts, the two pegs on the back of the gii post ref a/p blk sz 7 stayed attached to the patient's bone, once the block was removed.The pegs were able to be removed using a bone nibbler.A surgical delay of less than or equal to 30 minutes was reported.No other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the device pegs were retained in the bone after removal of the cutting block and a surgical delay of 0-30 minutes resulted.Reportedly, the pegs were removed using a bone nibbler.It was communicated that all pieces were recovered, and the procedure was completed without patient injury, additional interventions or adverse effects.Based on the information provided, the clinical root cause could not be definitively concluded.Patient impact beyond retrieval of the broken pieces and the 0-30-minute surgical delay would not be anticipated as no patient injury or adverse effects were reported.No further medical investigation is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no 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 likely 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.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.
Additional Manufacturer Narrative
D4: lot number and expiration date added h4: manufacture date added (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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 two pegs of the device have broken off, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that per complaint details, the device pegs were retained in the bone after removal of the cutting block and a surgical delay of 0-30 minutes resulted.Reportedly, the pegs were removed using a bone nibbler.It was communicated that all pieces were recovered, and the procedure was completed without patient injury, additional interventions or adverse effects.Based on the information provided, the clinical root cause could not be definitively concluded.Patient impact beyond retrieval of the broken pieces and the 0-30-minute surgical delay would not be anticipated as no patient injury or adverse effects were reported.No further medical investigation is warranted at this time.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: GII POST REF A/P BLK SZ 7
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11977130
• Report Number: 1020279-2021-05106
• Device Sequence Number: 3388839
• Product Code: HRY
• UDI-Device Identifier: 03596010407368
• UDI-Public: 03596010407368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121393
• 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,Followup,Followup
• Report Date (Section B): 10/22/2021

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: 71440822
• Device Catalogue Number: 71440822
• Device Lot Number: 12AM17551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 08/23/2021; 10/21/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/24/2021; 10/07/2021; 10/22/2021
• 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: Required Intervention