MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA MILLING CLAMP ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	I-K4112OT00
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a primary knee procedure, when the blade cutter of the device touches the patella, the joint to the patella jaws gets loose.A saw had to be used to complete the procedure successfully with no delay.This is the second time this has happened with this device and surgeon, another device of the same catalog number.No other information is available.
Additional Manufacturer Narrative
Update to event changed the subject device for this event.All fields applicable to device information have been corrected.An event regarding assembly issue involving a duracon clamp was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that during a primary knee procedure, when the blade cutter of the device touches the patella, the joint to the patella jaws gets loose.A saw had to be used to complete the procedure successfully with no delay.This is the second time this has happened with this device and surgeon, another device of the same catalog number.No other information is available.Update april 23, 2020: the surgeon provided additional information via the sales representative.He believes the mating device, patella milling clamp assembly, was the likely cause of this event.
Event or Problem Description
It was reported that during a primary knee procedure, when the blade cutter of the device touches the patella, the joint to the patella jaws gets loose.A saw had to be used to complete the procedure successfully with no delay.This is the second time this has happened with this device and surgeon, another device of the same catalog number.No other information is available.Update april 23, 2020: the surgeon provided additional information via the sales representative.He believes the mating device, patella milling clamp assembly, was the likely cause of this event.
Additional Manufacturer Narrative
Update to event changed the subject device for this event.All fields applicable to device information have been corrected.An event regarding assembly issue involving a duracon clamp was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: PATELLA MILLING CLAMP ASSEMBLY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9842088
• Report Number: 0002249697-2020-00533
• Device Sequence Number: 2929185
• Product Code: LXH
• UDI-Device Identifier: 07613327418965
• UDI-Public: 07613327418965
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I-K4112OT00
• Device Catalogue Number: 6633-7-765
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 06/13/2020; 06/13/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 07/10/2020; 07/15/2020
• 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: Other