MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STOP PLATE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	6543-7-602
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
"the stop plate does not assemble with the revision tibial resection guide (p/n 6543-6-701) as the chamfer on the right side of the block makes contact with the end of the block while the block is supposed to sit flush.When checking the stop plate dimensions, we found it does not meet the drawing specs." discovery made during product development/ testing, devices had been ordered directly from finished goods.No associated procedure.Devices have been delivered to the complaint handling department.A picture of the devices is attached.Reporter has requested investigation results.
Event or Problem Description
"the stop plate does not assemble with the revision tibial resection guide (p/n 6543-6-701) as the chamfer on the right side of the block makes contact with the end of the block while the block is supposed to sit flush.When checking the stop plate dimensions, we found it does not meet the drawing specs." discovery made during product development/ testing, devices had been ordered directly from finished goods.No associated procedure.Devices have been delivered to the complaint handling department.A picture of the devices is attached.Reporter has requested investigation results.
Additional Manufacturer Narrative
An event regarding assembly issue and dimensional defective part involving a triathlon plate was reported.The event was confirmed.Method & results: -device evaluation and results: ma: material analysis is not performed as this is not related to material integrity.Perform functional/dimensional.Visual inspection: visual inspection on the returned device had slight wear/damage throughout the part but nothing remarkable to report.Functions inspection: functional testing with the returned devices confirmed that the stop plate did not sit flush when assembled on the resection guide.Dimensional inspection: the device is dimensionally out of specification as per current drawing as per inspection completed by the stryker mahwah metrology lab.Inspection attached.However, this drawing was updated at which this dimension was changed.If the part was measured against the drawing that was current at time of manufacture, then the part is correct.Product in the field was dispositioned as "use as is".-clinician review: no medical records were received for review with a clinical consultant.-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.Event confirmed & root cause identified: the device is dimensionally out of specification as per current as per inspection completed by the stryker mahwah metrology lab.Inspection attached.However, this drawing was updated, at which this dimension was changed.If the part was measured against the drawing that was current at time of manufacture, then the part is correct.Product in the field was dispositioned as "use as is".No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: STOP PLATE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9328752
• Report Number: 0002249697-2019-03768
• Device Sequence Number: 10867458
• Product Code: FZX
• UDI-Device Identifier: 07613327247374
• UDI-Public: 07613327247374
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143393
• 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
• Report Date (Section B): 01/17/2020

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 Expiration Date: 08/31/2012
• Device Catalogue Number: 6543-7-602
• Device Lot Number: C2E06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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