MAUDE Adverse Event Report: AESCULAP AG KERRISON 15MM NOIR 130DEG UP 2; BONE PUNCH

Model Number FK982B

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Screw of the kerrison fell into the patient; x-ray was performed and the screw was not verified to be in the patient.Surgical delay was greater than 15 minutes.

Manufacturer Narrative

The screw on the upper slider is missing.The screw is not available for investigation.A visual investigation with digital microscope was performed.The device history files have been checked and were found to be according to the specifications valid at the time of production.No similar incidents have been filed with products from this batch.This error has been detected and capa was carried out and completed (03/02/2015).The product from this complaint was from a previous production.In the course of time the screw must have come loose and turned out of the upper slider.Based on the information available as well as a result of our investigation the root cause of the failure is most probably a design error, which has been corrected.

• Brand Name: KERRISON 15MM NOIR 130DEG UP 2
• Type of Device: BONE PUNCH
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5444602
• MDR Text Key: 38477740
• Report Number: 2916714-2016-00104
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FK982B
• Device Catalogue Number: FK982B
• Device Lot Number: 51995258
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/11/2016
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other