MAUDE Adverse Event Report: AESCULAP AG CUSHING RONGEUR STR 2X10MM180MM

Model Number FF803R

Device Problem Break (1069)

Patient Problem Missing Value Reason (3192)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During a intra-operative surgical procedure on lumbar laminectomy / discectomy l5-s1, pituray forcep tip broke off.Additional intervention (x-ray) was needed to retrieve the piece.Surgery was delayed for approximately 5 to 10 minutes.No patient injury reported.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.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 uneven pin is an indicator of an overload force, most likely a leverage effect.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rational: this kind of instrument is designed for delicate use only.It is almost certain that a mechanical overload situation led to the breakage.Visual investigation indicated tat the quality requirements are within the specified tolerance range.No capa is necessary.

• Brand Name: CUSHING RONGEUR STR 2X10MM180MM
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5600735
• MDR Text Key: 43448421
• Report Number: 2916714-2016-00330
• Device Sequence Number: 1
• Product Code: HTX
• 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
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF803R
• Device Catalogue Number: FF803R
• Distributor Facility Aware Date: 03/29/2016
• Date Manufacturer Received: 03/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other