MAUDE Adverse Event Report: AESCULAP AG TC NEEDLE HOLDER X-DEL SERR200MM; BASIC INSTRUMENTS

Model Number BM026R

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instrument is available for investigation decontaminated, but not the fragment.Investigation - failure description - the instrument is in a good condition, apart from the missing carbide inlay, no deviations can be found.Investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The backing material at the point of rupture is bent.Batch history review - the device quality and manufacturing history records for all available lot numbers has been requested.The answer is still pending; the report will be updated upon receipt of the review.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 an insufficient usage.Rationale - the bent backing material is a sign of an overload situation, most likely caused by leverage or torsion which caused the fracture of the carbide.

Event Description

It was reported that there was an issue with the needle holder.During an unspecified procedure, the jaw of the needle holder "broke".Additional information was not available.

• Brand Name: TC NEEDLE HOLDER X-DEL SERR200MM
• 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
• MDR Report Key: 8605514
• MDR Text Key: 144965910
• Report Number: 9610612-2019-00317
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/13/2019

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: BM026R
• Device Catalogue Number: BM026R
• Device Lot Number: 4509938697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/06/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1