MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA RESECT GUIDE - SLOTTED; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	6633-7-736
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
During a difficult primary knee replacement, the surgeon had trouble retracting the tibia anteriorly due to a tight patella tendon; the result of a prior tibial fracture.When the patella was resected, it fractured.Two 4mm x36mm cannulated screws were used to fix the fracture.Some threads of the screws were visible through the surface where the bone cement was to be applied.The patella was implanted and surgery continued as planned.
Additional Manufacturer Narrative
An event regarding intraoperative fracture involving a patella resection guide was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as no medical records were provided for review.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the event itself could not be confirmed nor could the exact cause of the event be determined because insufficient information was provided.Further information such as device evaluation, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During a difficult primary knee replacement, the surgeon had trouble retracting the tibia anteriorally due to a tight patella tendon; the result of a prior tibial fracture.When the patella was ressected, it fractured.Two 4mm x36mm cannulated screws were used to fix the fracture.Some threads of the screws were visible through the surface where the bone cement was to be applied.The patella was implanted and surgery continued as planned.

• Brand Name: PATELLA RESECT GUIDE - SLOTTED
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8451467
• Report Number: 0002249697-2019-01445
• Device Sequence Number: 11454492
• Product Code: FZX
• UDI-Device Identifier: 07613327230253
• UDI-Public: 07613327230253
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6633-7-736
• Device Lot Number: TACB340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: Hospitalization; Required Intervention