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

Model Number FF904SB

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ff904sb - caspar distraction pin 14mm.According to the complaint description, during the removal of the distraction pins, the head of 2 pins broke.Portions of the threads were left in the patient's body at c5 and c6.This occurred during a neurosurgical procedure.A fragment remained in situ.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Updated d9: not returned to manufacturer for evaluation.Updated h6: codes.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.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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
• Type of Device: 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: 14052782
• MDR Text Key: 289332666
• Report Number: 9610612-2022-00090
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Model Number: FF904SB
• Device Catalogue Number: FF904SB
• Device Lot Number: 52687660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1