MAUDE Adverse Event Report: AESCULAP AG ACTIV L REVISION DISTRACT.FORCEPS ANGLED; SPINE SURGERY

Model Number	FW965R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap ag that an activ l revision distract.Forceps angled (part # fw965r) was used during a l4-5 anterior lumbar interbody fusion (alif) total disc replacement (tdr) procedure performed on an unknown date.According to the complainant, the prongs were bent during repositioning.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.A surgical delay of approximately ten (10) minutes was reported.The patient outcome was noted as being "great".The malfunction was filed under aag 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
Additional information: b5: patient harm changed from unknown to significant surgery delay.Therefore no longer reportable.D9: device not returned to manufacturer.Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
Event or Problem Description
Additional information: patient harm changed from unknown to significant surgery delay.Therefore no longer reportable.

• Brand Name: ACTIV L REVISION DISTRACT.FORCEPS ANGLED
• Common Device Name: SPINE SURGERY
• 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: 13535810
• Report Number: 9610612-2022-00027
• Device Sequence Number: 4039482
• Product Code: LXH
• UDI-Device Identifier: 04038653431441
• UDI-Public: 4038653431441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• 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): 03/18/2022

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: FW965R
• Device Catalogue Number: FW965R
• Was Device Available for Evaluation?: No
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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
• Patient Sex: Unknown