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

Model Number	I-K4112OT00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/01/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Locking mechanism was too weak so the device spun out and cut open surgeon's hand.Case was completed successfully with a 5 - 10 minute delay.No additional information is available.
Additional Manufacturer Narrative
Additional information added to the event description, type or reportable event corrected to malfunction, device information updated.Update (b)(6) 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 and the sharp object that caused his wound.His wound did not require medical attention.After cleaning his hand and changing his glove, he completed that surgery successfully and performed other surgeries throughout the day.The surgeon is not returning the patella milling clamp for investigation.Update to the event indicates that the subject device for this complaint has changed and that the surgeons' wound did not require medical attention.Therefore, the reportability decision for this event is being corrected to malfunction.
Event or Problem Description
Locking mechanism was too weak so the device spun out and cut open surgeon's hand.Case was completed successfully with a 5 - 10 minute delay.No additional information is available.Update (b)(6) 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 and the sharp object that caused his wound.His wound did not require medical attention.After cleaning his hand and changing his glove, he completed that surgery successfully and performed other surgeries throughout the day.The surgeon is not returning the patella milling clamp for investigation.

• 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: 9246435
• Report Number: 0002249697-2019-03628
• Device Sequence Number: 14239608
• 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
• Report Date (Section B): 05/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• 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: 10/17/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 05/19/2020
• 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