MAUDE Adverse Event Report: AESCULAP AG KERRISON THIN-FT 130DG-UP 1MM 180MM; MICRO NEUROSURGICAL INSTR. / D

Model Number FF771R

Device Problems Bent (1059); Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It is reported that the tip of the instrument bent then broke during cervical surgery.It was difficult retrieving fragments of the instrument.All med watch submissions related to this report are: 2916714-2016-01010, 2916714-2016-01011.

Manufacturer Narrative

The components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.The broken tip is missing.The fracture surface shows signs of a forced fracture due to overload.Hardness of the instrument was checked and according to specification (420 +110 hv5/hv10) it is in the allowable tolerance with 455 hv5.The manufacturing documents have been checked and found to be according to specification valid during the time of production.The root cause of the problem is most probably user related.This kind of instrument is disigned for delicate use only.We assume a mechanical overload situation as the causal factor.A material defect can be excluded.According to the instruction for use, the following note and warning must be observed: "color-marked aesculap kerrison bone punches with a gold-colored distal working tip have a thin foot plate and may be used only removing small bone portions and soft tissue.Additionally, those aesculap kerrision bone punches carry the inscription "for delicate use only"" no capa is necessary.

• Brand Name: KERRISON THIN-FT 130DG-UP 1MM 180MM
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• 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: 6134846
• MDR Text Key: 61195740
• Report Number: 2916714-2016-01010
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF771R
• Device Catalogue Number: FF771R
• Device Lot Number: 52228883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/22/2016
• Device Age: 7 MO
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other