MAUDE Adverse Event Report: AESCULAP AG TC RYDER NEEDLE HOLDERX-DELSERR175MM; BASIC INSTRUMENTS

Model Number BM056R

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation: vigilance investigation carried out the pictorial documentation visually and microscopically.Both carbide inlays are not in place, only one has been provided.The provided carbide inlay is matching with the jaw part "a".The surface of jaw part "a" is even and without deviation, while at part "b" several small pressure marks can be found.These pressure marks were most likely caused during using a needle, after the inlay had already fallen off.It is not possible to determine when the inlay has fallen off.At the surfaces of the jaw, no solder resides can be found.Therefore, we assume that the solder joint was not manufactured according to the specifications valid at the time of production.No other similar complaint are listed, therefore we assume an individual issue.Batch history review: the device quality and manufacturing history record have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents 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 a manufacturing error.Corrective action: no other similar complaint, therefore we assume an individual issue.The q-coordinator of the production plant will be informed ad requested to initiate corrective measures.

Event Description

It was reported the jaw insert came loose and remained in situ.The reporter indicated that both carbide inserts of the needle holder became loose during surgery and fell off.One carbide insert was retrieved the other one wasn´t found.Therefore there is a possibility that it remained in situ.During cardiac surgery after the first stitch, the needle holder was opened and the surgeon recognized a part that had fallen into the patient.The part could be retrieved immediately and was 1mm wide and 5mm long.It also showed that the inserts were missing on both sides of the needle holder jaw.The entire in situ was examined after the second insert.In order to exclude anything remained in the vessel, an arterial flushing with saline solution was performed.Several x-rays were taken to further exclude the foreign body from remaining in situ.No foreign bodies were detected, however, since the broken part was still not found, a potential retention of the part in the patient cannot be completely excluded.

• Brand Name: TC RYDER NEEDLE HOLDERX-DELSERR175MM
• Type of Device: BASIC INSTRUMENTS
• 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8660350
• MDR Text Key: 146813019
• Report Number: 9610612-2019-00362
• Device Sequence Number: 1
• Product Code: HXK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM056R
• Device Catalogue Number: BM056R
• Device Lot Number: 4507422606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/21/2019
• Device Age: 36 MO
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention