MAUDE Adverse Event Report: AESCULAP INC. PATELLA GUIDE SIZER/GUIDE ASSEMBLY P2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MF604R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a patella guide sizer/guide assembly p2 (part # mf604r) was used during a total knee replacement procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the spike on the backside of the instrument detached into the patient.The spike was retrieved, and then the procedure was continued and successfully completed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The adverse event / malfunction is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Reportedly, the construction of pin assembly created using laser welding process.However, the part could not be identified through laser marking due to fading.Therfore, the part was determined to have exceeded its lifetime usage.The device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the reported event was able to confirm the spike detachment.Due to the fading of the laser weld marking, it was determined that the useful life of the device had been exceeded.

• Brand Name: PATELLA GUIDE SIZER/GUIDE ASSEMBLY P2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 13517428
• Report Number: 2916714-2022-00002
• Device Sequence Number: 5397143
• Product Code: LXH
• UDI-Device Identifier: 04046955236503
• UDI-Public: 4046955236503
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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 Model Number: MF604R
• Device Catalogue Number: MF604R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown