MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC PRI SPACER BLOCK; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441265

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

It was reported that, during tka surgery, the piece of o-ring inside gii spc pri spacer block has broken off.Piece was located and taken out of patient.It is unknown if there was a s&n backup device available.Surgery was not delayed.Patient was not harmed.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, during tka surgery, the piece of o-ring inside gii spc pri spacer block has broken off while outside the patient.The device chipped upon removal and the piece was hanging on slightly.No pieces fell inside the patient.It is unknown if there was a s&n backup device available.Surgery was not delayed.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it was reported that during a tka surgery, a piece of the o-ring inside of the gii spc pri spacer block was broken off.Per the e-mail correspondence, no pieces fell inside of the patient.The e-mail also stated the o-ring ¿chipped upon removal and the piece was hanging on slightly.No further information was provided for review.Based on the information provided, the procedure was completed without delay.No harm to the patient was reported.Therefore, no further clinical/medical assessment is warranted at this time.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 complaint history revealed similar events for the listed device, but no similar events for the batch, 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.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

• Brand Name: GII SPC PRI SPACER BLOCK
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 12988231
• MDR Text Key: 282191302
• Report Number: 1020279-2021-08636
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556034354
• UDI-Public: 00885556034354
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 71441265
• Device Catalogue Number: 71441265
• Device Lot Number: 11FM09811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 02/18/2022; 02/16/2022
• Supplement Dates FDA Received: 02/18/2022; 02/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1