MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA RESECT GUIDE - STYLUS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	6633-7-738
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, right knee.It was reported that in using the patella resection stylus, the spring has become lax and will not hold without difficulty.Surgeon wants the device replaced.Rep reported that there was no surgical delay caused.
Event or Problem Description
Primary procedure, right knee.It was reported that in using the patella resection stylus, the spring has become lax and will not hold without difficulty.Surgeon wants the device replaced.Rep reported that there was no surgical delay caused.
Additional Manufacturer Narrative
An event regarding alleged assembly issue involving a duracon clamp was reported.The event was not confirmed.Clinician review: not performed as medical records were not received for review with a clinical consultant.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the returned device was found to be functional.A functional inspection was performed and assembled as intended with the patellar resection guide (cat.6633-7-736, lot.Rdde051) from finished goods.Materials engineer indicated in-service use damages observed on the returned product.Evidence of masterbond debris was observed on the threads of the device, potentially due to disassembly.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.If additional information is received, this investigation will be reopened and re-evaluated.

• Brand Name: PATELLA RESECT GUIDE - STYLUS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7689479
• Report Number: 0002249697-2018-02166
• Device Sequence Number: 2771730
• Product Code: JWH
• UDI-Device Identifier: 07613327230000
• UDI-Public: 07613327230000
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 09/11/2018

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 Catalogue Number: 6633-7-738
• Device Lot Number: RD3S195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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