MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT BICORTICAL SCREW 35MM; NAVIGATION SYSTEMS AND SUPPORT

Model Number	NP621R
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with np621r - orthopilot bicortical screw 35mm.According complaint description a (b)(6) female patient who underwent tka using orthopilot on (b)(6) 2020, fell and suffered an oblique fracture of the femoral shaft.The onset of the fracture was observed in the vicinity of the screw hole in the femeur that was made using a bicortical screw.Ct scan examination revealed a fracture line running from the screw hole.The surgeon stated that cause of the post operative fracture is obviously the patient's fall, but that the femeur might have been more vulnerable to fracture as a result of the hole.Revision is schedule to reinforce the femeur using a plate.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: to date there is no device available for investigation.Therefore, no investigation possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect, manufacturing failure or design error on the basis of the device history record.For further investigations we need the product for examination.Based on the investigations and results of the 8d report a capa is not necessary.

• Brand Name: ORTHOPILOT BICORTICAL SCREW 35MM
• Common Device Name: NAVIGATION SYSTEMS AND SUPPORT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10792890
• Report Number: 9610612-2020-00735
• Device Sequence Number: 16977798
• Product Code: LXH
• UDI-Device Identifier: 04038653331727
• UDI-Public: 4038653331727
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: A883011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: NP621R
• Device Catalogue Number: NP621R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: Required Intervention
• Patient Age: 73 YR