MAUDE Adverse Event Report: AESCULAP AG TC NELSON-METZ SCISSORS DEL CVD 285MM; BASIC INSTRUMENTS

Model Number BC281R

Device Problems Fracture (1260); Material Integrity Problem (2978)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary investigation: a visual inspection of the instrument and of the fracture surface.The instrument was sent to the production department for further investigation.The report will be updated when we receive a statement from the production department.Batch history review: the device quality and manufacturing history records will be checked for the lot number 4509144704 from the quality coordinator of the production plant.After review, the report will be updated.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause could be manufacturing related.The report will be updated when we receive a statement from the production department.Rationale: due to the circumstance that the product has been sent to the manufacturer for an analysis this is a preliminary report and it will be updated when we receive a statement from the manufacturer.Investigations lead to the assumption that the scissor part was damaged before soldering the carbide due to the signs of soldering deposits.There is also the possibility that the scissor part was not completely pronounced or was damaged during production.We are currently unable to determine any fracture surface.When additional information is received a follow up report will be submitted.

Event Description

It was reported a missing piece was seen on scissor blade.The reporter indicated that during the packing process it was noticed that a piece of the blade broke off.It is unknown where the broken part is located.Per the reporter, the broken piece was so small that it was noticed only during the packaging process and unfortunately not earlier and it is possible that this could have happened weeks ago.No additional information has been provided.

Manufacturer Narrative

Aesculap inc.(importer, registration no.(b)(4)) is submitting this report on behalf of aesculap ag (manufacturer, registration no.(b)(4)).Exemption number: (b)(4).Investigation: the investigation was carried out visually and microscopically with the digital microscope.Here we found unknown deposits.Furthermore we made a functional test and found a mechanical malfunction, the scissor is not opened.Here we detected a failed connection to the guiding rail.Furthermore we discovered a bent scissor blade.Batch history review: the device quality and manufacturing history records have been checked for the lot number (524936560) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause is most probably usage related.Rationale: according to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the bent scissor blade was caused due to a mechanical overload situation or leverage during opened blade.The bent scissor blade led to the failed connection to the guiding rail and to the mechanical malfunction.No capa necessary.

• Brand Name: TC NELSON-METZ SCISSORS DEL CVD 285MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8588936
• MDR Text Key: 144969631
• Report Number: 9610612-2019-00307
• Device Sequence Number: 1
• Product Code: LRW
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC281R
• Device Catalogue Number: BC281R
• Device Lot Number: 4509144704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Distributor Facility Aware Date: 06/03/2019
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1