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 2017-08-25 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[83649502]
Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: what is the product name? - not known. Device will be returned for evaluation so can be confirmed on receipt by investigator. The date reported to (b)(4) rep - (b)(6); this has been logged in the event details section. Date of event - (b)(6); this has been logged in the event details section. Product has been marked "available for return" - please provide contact name and number for collection - can you please advise why is this information being requested? It is the affiliate's responsibility to arrange product collection. Product code/lot number - n/k.
Patient Sequence No: 1, Text Type: N, H10
[83649503]
It was reported that the patient underwent a laparoscopic band redo procedure on (b)(6) 2017 and the unknown suture was used. During the procedure, the needle broke. The tip broke off and was captured out of the patient. There were no adverse patient consequences reported and no reported delay to the procedure.
Patient Sequence No: 1, Text Type: D, B5
[96764611]
(b)(4). A failed suture needle, was returned for evaluation. A fracture was observed at the tip of the needle. The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation. A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle. The fracture surfaces were examined in multiple locations in order to determine the fracture mode. The evaluation found evidence of a ductile overload failure. Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload. This was a ductile fracture. The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload. There is no evidence of any material flaw or defect that would cause premature failure. In order to avoid this kind of damage the package insert (ifu) cautions: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.
Patient Sequence No: 1, Text Type: N, H10
[106792893]
(b)(4). The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2017-70075 |
| MDR Report Key | 6820588 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-25 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-11-02 |
| Device Manufacturer Date | 2016-12-30 |
| Date Added to Maude | 2017-08-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON, INC. SAN LORENZO |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO PR 00754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2017-08-25 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-25 |