MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-13 for TC NEEDLE HOLDER X-DEL SERR200MM BM026R manufactured by Aesculap Ag.
[144965910]
(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.
Patient Sequence No: 1, Text Type: N, H10
[144965911]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00317 |
| MDR Report Key | 8605514 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-13 |
| Date Facility Aware | 2019-05-06 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2018-09-29 |
| Date Added to Maude | 2019-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC NEEDLE HOLDER X-DEL SERR200MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | HXK |
| Date Received | 2019-05-13 |
| Returned To Mfg | 2019-04-29 |
| Model Number | BM026R |
| Catalog Number | BM026R |
| Lot Number | 4509938697 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-13 |