MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for CLASSIC PLUS 36-2002 manufactured by Symmetry Surgical Inc.
[119503852]
Reported product: 36-2002. Description: classic plus? Needle holder, crile-wood, 8 in. Dear valued customer, symmetry surgical is providing this summary in response to the incident involving the crile-wood needle holder. We apologize for any inconvenience this issue may have caused. The quality assurance investigation is complete with the following results: unfortunately, the needle holder was unable to be returned for a physical evaluation. A remote evaluation was accomplished using pictures provided of the broken instrument. Pictures showed that a piece of the tungsten carbide insert broke off the needle holder and that the instrument had been etched with a may 2018 repair code. Since the lot number was polished off we were unable to determine the exact date the instrument was purchased. We sent all pictures and information to our repair facility, five star, for investigation. They confirmed that the repair code etched on the instrument was theirs. Through their assessment they determined that the insert did not fail due to poor workmanship but likely failed due to a small hair line crack in the insert. The small hair line crack likely occurred due to excessive force or impact to the insert region, therefore weakening the insert and causing it to partially break off in the manner depicted in the photos. Thank you for your patience during the investigation of this issue. If you have any questions or concerns, please feel free to contact me. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119503853]
Needle holder (refurbished in may 2018) tungsten carbide insert broke off during a case and is currently retrained in the patient, confirmed by chest x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2018-00019 |
| MDR Report Key | 7844472 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-04 |
| 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 | MS. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC |
| Manufacturer Street | 3034 OWEN DRIVE |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLASSIC PLUS |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2018-09-04 |
| Model Number | 36-2002 |
| Catalog Number | 36-2002 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC |
| Manufacturer Address | 3034 OWEN DRIVE ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-04 |