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

Model Number	FF904SB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a caspar distraction pin 14mm (part # ff904sb) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the surgery, while attempting to remove the pin, the tip of the device broke off into patients anterior vertrebal body.The fragment remained in situ as to minimize likelihood of patient harm.The complaint device was not returned to the manufacturer for evaluation.No patient complications have been reported as a result of this event.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.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
• MDR Report Key: 12050806
• Report Number: 2916714-2021-00124
• Device Sequence Number: 17111257
• Product Code: LXH
• UDI-Device Identifier: 04038653364305
• UDI-Public: 4038653364305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021
• Report Date (Section F): 06/23/2021

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: 10/22/2025
• Device Model Number: FF904SB
• Device Catalogue Number: FF904SB
• Device Lot Number: 52645613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2021
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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
• Date Report Sent to FDA: 06/23/2021