MAUDE Adverse Event Report: AESCULAP AG LOVE-GRUENWALD RONGEURSTR2X10MM135MM; BONE PUNCHES, RONGEURS

Model Number FF799R

Device Problem Break (1069)

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation on-going.

Event Description

Country of complaint: (b)(6).At l5 - s1 right articular cyst surgery, one of the jaws of the clamp broke during the discectomy and got stuck in the intercorporeal space, impossible to extract.No clinical consequence for the patient, a reoperation is expected in the coming days.

Manufacturer Narrative

Investigation the investigation was carried out visually.The analysis of the fracture pattern illustrates a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The blade is blunt, it is liable that the instrument was used to prepare bones.Also the widened mechanism and the non-flush pin are indicators of leverage forces.The taped and sandblasted surface of the instrument indicates a third party maintenance, this is not according to the ats specification.Batch history review not applicable, due to foreign maintenance.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 user related.Rational: this kind of instruments is designed for delicate use only.It is liable a mechanical overload situation led to the breakage.The breakage of the movable part was most likely caused by a leverage force.Corrective action according to sop sa-de13-m-4-2-01-010 a capa is not necessary.

• Brand Name: LOVE-GRUENWALD RONGEURSTR2X10MM135MM
• Type of Device: BONE PUNCHES, RONGEURS
• 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: 6403719
• MDR Text Key: 70364519
• Report Number: 9610612-2017-00086
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF799R
• Device Catalogue Number: FF799R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/14/2017
• Date Manufacturer Received: 02/13/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other