MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEUR UP-BITE 2MM 155MM; BONE PUNCH

Model Number FF842R

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).The top end of the device broke off inside the patient.This resulted in the patient being under anesthesia for a prolonged period of time; additionally, the patient was x-rayed following surgery and again the next day.

Manufacturer Narrative

A complaint was received regarding a rongeur with a broken-off jaw.The moveable jaw is broken off.Crack and stretch marks are visible on the lower jaw part.Traces of decomposing are visible on the screw.Investigation was performed, using the digital microscope vhx-600 by (b)(4) and the hardness tester.The crack and stretching marks suggest that strong torsion forces have acted on the distal end of the device.The signs of decomposing on the screw indicates a unprofessional repair, no stamp of ats can be found on the instrument, a review of the device history is not possible, because with the given identification number on the instrument, no matches could be found in our system.Based on the information available as well as a result of our investigation the root cause of the failure is most probably user related and caused by an insufficient maintenance of the device.According to sop (b)(4) a capa is not necessary.

• Brand Name: CASPAR RONGEUR UP-BITE 2MM 155MM
• 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: 5444606
• MDR Text Key: 38476744
• Report Number: 2916714-2016-00116
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/18/2016

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: No Information
• Device Model Number: FF842R
• Device Catalogue Number: FF842R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/15/2016
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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