MAUDE Adverse Event Report: AESCULAP AG TC CONVERSE NEEDLE HOLDER SERR 130MM

Model Number BM011R

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the platform of a needle holder is constantly chipping and breaking off.No adverse events have been reported; no patient injury or prolonging of surgeries reported.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the jaw part of the instrument.Here we found a broken off carbide insert ta009994.Additionally we found dark, golden, and brown discoloration.Furthermore we found gaps between the jaw and carbide insert.We also found pitting.Additionally we found unknown deposits and unpronounced teeth.Batch history review: the device quality and manufacturing history records have been checked for the lot number 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 of the problem is most probably reprocessing or maintenance related.Rational: according to the quality standard, a material defect or production error can be excluded.No pores, inclusions, or foreign bodies could be found on the point of rupture.We assume an etching effect on the soldered seams and carbide insert as the causal factor.This could have been caused due to effects of acid due to over dosing of neutralizing chemicals or due to using acid based cleaners.Furthermore there is the possibility that the soldering joint was damaged by an insufficient drying and/or laying in a damp solution for a longer time.If the solder seam is not complete there is the possibility for breakage of the carbide insert.Additionally, due to the pre damage of the soldered seam, the carbide insert could break off because of an insufficient handling and/or dropped on a hard surface.We assume that the unpronounced teeth and pitting were caused due to etching effect.Additionally we assume that the black and brown discoloration are dark staining and material erosion at the soldering points and corrosive deposits.No capa is necessary.

• Brand Name: TC CONVERSE NEEDLE HOLDER SERR 130MM
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5926345
• MDR Text Key: 53900053
• Report Number: 2916714-2016-00784
• Device Sequence Number: 1
• Product Code: HXK
• 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: 06/29/2018

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: No Information
• Device Model Number: BM011R
• Device Catalogue Number: BM011R
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2016
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: 08/08/2016
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other