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

Model Number	FF904SB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
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
Kw 05-06-2021.It was reported aesculap ag that a caspar distraction pin 14mm (part # ff904sb) was used during an unknown proccedure performed on (b)(6), 2021.According to the complainant, the screw broke during surgery.Rupture with intraosseous sequestration of a caspar distraction screw during the intervention of a cure for c6-c7 pseudo-arthrosis and installation of osd plate.Consequence: persistence of material at level c6.A fragment of the broken device reamined in situ.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
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: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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: CASPAR DISTRACTION PINS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11571959
• Report Number: 9610612-2021-00206
• Device Sequence Number: 17231406
• Product Code: LXH
• UDI-Device Identifier: 04038653364305
• UDI-Public: 4038653364305
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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 Model Number: FF904SB
• Device Catalogue Number: FF904SB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: Required Intervention