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

Model Number FF904SB

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.(b)(4).

Event Description

It was reported by the healthcare professional "the surgeon was performing a surgical procedure to remove the distraction pins, the pins broke off from the flesh on the bone.The surgeon decided to leave the fragment part of the pins in the bone because trying to remove them would cause more harm than leaving them in the patient.The areas were covered with bone wax and no metal was left exposed.The surgery time was extended due to the attempts to remove the fractured pins." delay in surgery length of time unknown.No other harm to patient reported, other than the pins left in the patient.All medwatch submissions related to this patient are: this report, 9610612-2019-00035.

Manufacturer Narrative

Associated reports: 9610612-2019-00035.Investigation: no product at hand.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: this is the only complaint out of the manufacturing lot.The error pattern is typical for mechanical overstress of a multi axial stress condition of bending and torsion.A material failure or a manufacturing error can be excluded.No capa is necessary.

• Brand Name: CASPAR DISTRACTION PIN 14MM
• Type of Device: IMPLANTS CERVICAL STABILISATIO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8267643
• MDR Text Key: 133751109
• Report Number: 9610612-2019-00034
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: FF904SB
• Device Catalogue Number: FF904SB
• Device Lot Number: 52434217
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/25/2019
• Device Age: 5 MO
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 94