MAUDE Adverse Event Report: AESCULAP AG AMESON TENOTOMY SCISSDELCVDB/B150MM; SURGICAL SCISSORS

Model Number BC177R

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the screw fell out and the blade broke in half.

Manufacturer Narrative

Investigation: the investigation was performed using a (b)(4).The hardness test confirmed the pre-set values.Target: 530 hv5.Current: 562 hv5.Batch history review: the device quality and manufacturing history records have been checked for the available lot numbers and have found to be according to specification valid at the time of production.One similar incident have been filed with products from this batch.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 insufficient maintenance of the device.Rational: the corrosion on the fracture of the scissors is a so-called "stress corosion" in combination with a mechanical tension.This type of corrosion often affects areas or components subject to high tensile stresses due to design such as screw connections.Reprocessing of the instrument in a state of high tension (in this case most likely fully closed during reprocessing) can speed up the defect.No capa is necessary.

• Brand Name: AMESON TENOTOMY SCISSDELCVDB/B150MM
• Type of Device: SURGICAL SCISSORS
• 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: 6831133
• MDR Text Key: 83996496
• Report Number: 9610612-2017-00447
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/08/2017

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: Health Professional
• Device Model Number: BC177R
• Device Catalogue Number: BC177R
• Device Lot Number: 4507914008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/28/2017
• Device Age: 11 MO
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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