MAUDE Adverse Event Report: AESCULAP AG ACTIV L SPACER F/H14MM; INSTRUMENTS SPINAL MOTION

Model Number	FW954R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
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 fw954r - activ l spacer f/h14mm.According to the complaint description, the shaft of the device bent during surgery.Surgeon used the spacers to attempt to open the disc space.The shaft of the product bent due to the forces applied.There was no described patient harm.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00414 (400513037 + fw953r).
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00414 (400513037 + fw953r).9610612-2021-00415 (400513038 + fw954r).
Additional Manufacturer Narrative
Additional information - d9 investigation results: visual investigation: we made a visual inspection of both spacers.The fw954r is bent sidewards at the 11° end.The 6° end is in a proper condition and according to the specification.The fw953r is twisted axially slightly at the 11° end.The 6° end is in a proper condition and according to the specification.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.The review of risk assessment revealed that the overall risk level (severity 6(10) x probability of occurrence 2(10) according to din en iso 14971 is still acceptable.Explanation and rationale: the most probable root cause for the deformations may be excessive force during usage.Conclusion and measures / preventive measures: based upon the investigation results, a clear conclusion cannot be determined.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ACTIV L SPACER F/H14MM
• Common Device Name: INSTRUMENTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11794252
• Report Number: 9610612-2021-00415
• Device Sequence Number: 4181207
• Product Code: LXH
• UDI-Device Identifier: 04038653425563
• UDI-Public: 4038653425563
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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 Model Number: FW954R
• Device Catalogue Number: FW954R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown