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

Model Number	FF904SB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results are received, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with a caspar distraction pin via information received from mw (b)(4).According to the complaint description, the pin broke during a spinal procedure and remained in situ.Distraction pin sheared when surgeon attempted to remove it from c3 (it sheared without any above average amount of force).The piece broke off in the bone and there was no intervention performed.There was also no surgical delay.A portion of the pin was fully embedded in bone without any potential to cause harm.Additional details were not provided.The malfunction is filed under xc reference (b)(4).
Event or Problem Description
No changes required.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: CASPAR DISTRACTION PIN 14MM
• Common Device Name: IMPLANTS CERVICAL STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12446829
• Report Number: 2916714-2021-00180
• Device Sequence Number: 19928997
• Product Code: LXH
• UDI-Device Identifier: 04038653364305
• UDI-Public: 4038653364305
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022
• Report Date (Section F): 09/09/2021

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 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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 04/06/2022
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/09/2021