MAUDE Adverse Event Report: AESCULAP AG CASPAR DISTRACTION PIN 14MM; IMPLANTS CERVICAL STABILISATION

Model Number	FF904SB
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
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 ff904sb - caspar distraction pin 14mm via information received from mw 0504140000-2021-8002.According to the complaint description, the pin broke during surgery and remained in situ.Distraction pin sheared when surgeon attempted to remove it from c3.(it sheared without any above average amount of force).A portion of the pin was fully embedded in bone without any potential to cause harm.The piece broke off in the bone.It would not have been safe to remove it.No surgery delay.A fragment reamined in situ.Additional details were not provided.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results:[updated with lot numbers].Due to lack of the product, an investigation is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specifications valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale /conclusion and root cause: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Corrective action: a capa is not necessary.

• Brand Name: CASPAR DISTRACTION PIN 14MM
• Common Device Name: IMPLANTS CERVICAL STABILISATION
• 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: 12442381
• Report Number: 9610612-2021-00614
• Device Sequence Number: 4853501
• Product Code: LXH
• UDI-Device Identifier: 04038653364305
• UDI-Public: 4038653364305
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/06/2022

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 Expiration Date: 09/28/2025
• Device Model Number: FF904SB
• Device Catalogue Number: FF904SB
• Device Lot Number: 52639069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Male