MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII XR POSTERIOR TIB KEEL PUNCH SZ 3-4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74014542
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka procedure, one jii xr posterior tib keel punch sz 3-4 and one jii xr tibia anterior keel punch sz 3-8 cracked while being impacted.Both devices cracked outside the patient, therefore no pieces fell inside the wound.It is unknown how the procedure was completed or if this caused any delay.No patient harm reported.
Additional Manufacturer Narrative
B5, h1 were corrected due to new information received.
Event or Problem Description
It was reported that during a tka procedure, when using a jii xr posterior keel punch tib sz 3-4 ((b)(4)) and a jii xr tibia sz 3-8 anterior keel punch ((b)(4)) a vertical fracture of 2-3 mm non displaced was observed in the tibia.The surgery was completed as planned with the implantation and the xr tibia baseplate and no further action was taken to treat the crack.It is unknown if there was any delay or the patient outcome.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a non-displaced 2-3mm vertical tibial fracture was observed when using a jii xr posterior keel punch tib sz 3-4 ((b)(4)) and a jii xr tibia sz 3-8 anterior keel punch ((b)(4) during the tka procedure.Reportedly the implantation of the xr tibia baseplate was completed using the same instrument, as planned/without further intervention or delay, and no further action was taken to treat the noted fracture.It was communicated that the patient status would not be known until the post-op visit.The clinical root cause of the reported event could not be definitively concluded based on the limited information provided.The patient impact beyond the reported non-displaced 2-3mm vertical tibial fracture could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available and/or a product evaluation conclusion results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but are not limited to user/procedural error.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.

• Brand Name: JII XR POSTERIOR TIB KEEL PUNCH SZ 3-4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12303850
• Report Number: 1020279-2021-06272
• Device Sequence Number: 11754934
• Product Code: JWH
• UDI-Device Identifier: 00885556744444
• UDI-Public: 885556744444
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K200227
• 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
• Report Date (Section B): 10/06/2021

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 Catalogue Number: 74014542
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/11/2021; 10/05/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/16/2021; 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1