MAUDE Adverse Event Report: AESCULAP AG TC HALSEY NEEDLE HOLDER SERR 130MM; GENERAL SURGICAL INSTRUMENTS

Model Number BM012R

Device Problems Break (1069); Corroded (1131); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with needle holder.It was reported that the surgeon noted the error before use, when picked up the device and prior to use on the patient.It was noted that the tip was missing so he did not use it on the patient.It was confirmed that the devices did not break in the sterile field and none have fallen in or had to be removed form a patient.There was no patient harm.An additional medical intervention was not necessary./ this event/malfunction did not prolong the surgery.The adverse event / malfunction is filed under (b)(4).

Event Description

Associated medwatch report: (b)(4).

Manufacturer Narrative

Correction/additional information after sample receipt it was noticed that this complaint includes several devices with several batches.Therefore a supplemental report will be sent for each batch.

Manufacturer Narrative

Investigation results after receipt of the goods: the needle holders are in a worn condition, the tungsten carbide inlays are broken off, the fragments are not available for investigation.Signs of corrosion can be found at the solder joint.The traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr -device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.The failure is most probably caused due to insufficient maintenance of the device.Discoloration and erosion of materials at solder points and sintered carbide inserts made of tungsten carbide and cobalt can be caused by chemical and electrochemical effects only in connection with an excessive acid content with stainless steel, soldering points and/or long-term impact of water/condensate in the case of stainless steel.Erosion most likely lead to breakage of the carbide inlays.For safe usage a correct reporcessing is necessary.Further information can be found in the reprocessing of instruments to retain value.

Event Description

Medwatch report: 9610612-2020-00211 - bm012r - 400473679 - quantity: 3.Associated medwatch report: 9610612-2020-00386 - bm012r - 400479837 - quantity: 1.

• Brand Name: TC HALSEY NEEDLE HOLDER SERR 130MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10168326
• MDR Text Key: 195615384
• Report Number: 9610612-2020-00211
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

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: BM012R
• Device Catalogue Number: BM012R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/02/2020; 08/07/2020
• Supplement Dates FDA Received: 07/31/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1