MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 2X12MM160MM

Model Number FF532R

Device Problem Break (1069)

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

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).The surgeon reported that during a herniated disk surgery, while using the clamp, it broke and part of the jaw fell into the wound.

Manufacturer Narrative

The received device was determined to have been manufactured prior to 1986, based on the format of the item number inscribed on the device.The upper jaw of the device was broken off.The instrument was analyzed using a digital microscope by (b)(4).The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The forced fracture is also confirmed by the bent rod near the breakage.Most likely the rongeur was used under torsional force while gripping.Based on the information available as well as a result of our investigation the root cause of the failure is most probably user related.Corrective/preventive action is not required.

• Brand Name: CASPAR RONGEURSTRSERR 2X12MM160MM
• Type of Device: RONGEUR
• 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: 5841912
• MDR Text Key: 51001797
• Report Number: 2916714-2016-00633
• Device Sequence Number: 1
• Product Code: HTX
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF532R
• Device Catalogue Number: FF532R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/22/2016
• Date Manufacturer Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other