MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-23 for INSTRUMENT 3747102 SUTURE PASSER manufactured by Integra York, Pa Inc..
[41266976]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[41266977]
Dealer initially reports device broke during surgery - tip snapped off. On (b)(6) 2016 customer reports eyelid surgery being performed. Broken piece retrieved without problem, no harm done.
Patient Sequence No: 1, Text Type: D, B5
[44704698]
On 4/29/16 integra investigation completed. Manufacture date unknown. Method : failure analysis, device history evaluation. Results : failure analysis - suture passer returned in used condition, wear and broken tip, not showing any unusual markings. The complaint report is confirmed. Device history evaluation - dhr review was completed with all history available. Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion : the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00035 |
| MDR Report Key | 5520023 |
| Date Received | 2016-03-23 |
| Date of Report | 2016-02-24 |
| Date Mfgr Received | 2016-04-29 |
| Date Added to Maude | 2016-03-23 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTRUMENT 3747102 SUTURE PASSER |
| Generic Name | PFM11 |
| Product Code | KAD |
| Date Received | 2016-03-23 |
| Returned To Mfg | 2016-03-01 |
| Catalog Number | 3747102 |
| Lot Number | 0208857775 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-23 |