MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS/G I-II. CIRCLIPS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6466-9-230
Medical Device Problem Codes	Component Incompatible (1108); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the circlip used to lock the axle in place was too small to properly lock the axle.Update: 5 minutes surgical delay.
Event or Problem Description
It was reported that the circlip used to lock the axle in place was too small to properly lock the axle.Update: 5 minutes surgical delay.
Additional Manufacturer Narrative
An event regarding assembly issue involving a custom hmrs circlip was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection was performed by lisi medical and indicated the following comments: the hmrs/g i-ii.Circlips showed distortion: the device is oval and not circular dimensional inspection was performed by lisi medical and indicated the following comment: dimensional inspection was performed according to the drawing number 454-b revision c: -wire diameter 0.90+/-0.02 mm: 0.88 mm - compliant -height 13.00 +/- 0.215 mm: 12.92 mm - compliant -flatness (visual inspection) - compliant -gauge 6.00+/-0.15 mm: 5.35 mm - not compliant the gauge of the device is dimensionally not compliant -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.Conclusion the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and return of the mating devices are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: HMRS/G I-II. CIRCLIPS
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9162681
• Report Number: 0002249697-2019-03415
• Device Sequence Number: 13931399
• Product Code: KRO
• UDI-Device Identifier: 04546540276520
• UDI-Public: 04546540276520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122015
• 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): 01/21/2020

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: 12/31/2022
• Device Model Number: 6466-9-230
• Device Catalogue Number: 6466-9-230
• Device Lot Number: G7265432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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