MAUDE Adverse Event Report: AESCULAP AG CASPAR DISTRACTION PIN 14MM; SPINE SURGERY

Model Number	FF904SB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap aag that a caspar distraction pin 14mm (item # ff904sb) was used during an anterior cervical discectomy and fusion (acdf) procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the distraction pin broke off into the cervical vertebrae and could not be removed.The procedure was completed with another aesculap distraction pin.The top tip of the complaint device was returned to the manufacturer for evaluation.A fragment remained in situ.The adverse event is 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.
Event or Problem Description
Update: the malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: we received a distraction pin (ff904sb) with broken off tip.We made a visual inspection of the fracture surface.Here we found the typical signs of a multi axial stress condition of bending and torsion.The yellow lines marking the bending and torsion lines, the red hatched area marks the residual forced fractured area.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the lot 52768652 contains 4000 pins.This is the only complaint out of this lot.The dhr shows no signs of deviation to the specifications during production.The error is typically for mechanical overstress of a multi axial stress condition of bending and torsion.A material failure or a manufacturing error can be ruled out.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably mechanical overstress.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: CASPAR DISTRACTION PIN 14MM
• 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: 16125125
• Report Number: 9610612-2023-00006
• Device Sequence Number: 6548069
• Product Code: LXH
• UDI-Device Identifier: 04038653364305
• UDI-Public: 4038653364305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: FF904SB
• Device Catalogue Number: FF904SB
• Device Lot Number: 52768652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown