MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for NEURAWRAP NERVE PROTECTOR 5MM ID X 4CM LENGTH NW540 manufactured by Integra Lifesciences Corporation.
[68356531]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[68356532]
1 of 3 reports - other mfg report numbers: 3003418325-2017-00007, 3003418325-2017-00008. It was reported that the patient had inflammation and rejection of the wrap. Additional information received from the surgeon on february 17, 2017 the patient had carpal tunnel release and trigger finger release surgeries 1 year ago. He developed a severe staph infection, very severe? Almost sepsis. No protective wrap implants were used for these procedures. Following his recovery from infection the patient? S carpal tunnel improved but then got worse. Due to the history and severity of infection, surgeon waited a year before planning a revision. During the revision surgery there was increased scar tissue/adhesions. This influenced his decision to use the? Protective wrap.? Two weeks postop the patient began to exhibit signs and symptoms of infection in his wrist. He returned to the or with the patient. He did not open the thumb. The thumb incision looked good. The wrist had completely opened and dehisced. There was very pronounced inflammation,? Almost like a rind.? It was not a small amount of inflammation;?? It was an extraordinary amount of inflammation, the incision burst open over the wrap but the ends of the incision remained intact.? But there was no pus. Since there was no puss, he decided it must be a reaction to the wrap. He removed the wrap. He obtained a culture specimen and sent the wrap to the pathologist. Culture results showed a staph infection. Pathology results showed marked inflammation. Statement from the surgeon:? I soak the wrap in normal saline for 5 minutes. I perform a running suture with 6. 0 or 7. 0 prolene. I use the recommended technique to implant the wraps.?
Patient Sequence No: 1, Text Type: D, B5
[71591090]
Integra has completed their internal investigation on march 9, 2017. The investigation included: methods: review of device history records, review of complaints history. Results: no complaint unit was received for evaluation since the product was implanted in the patient neither the pathologist results from the client have been received. Therefore, the failure analysis could not be performed at this time. Ten (10) retain samples of fg lot 1153778 were visually evaluated for product and packaging appearance to confirm no deterioration. No signs of deterioration were found during the retain samples visual evaluations and a good seal (continuous and evenly compressed) along the entire seal length was observed on each packaging tray. Visual evaluation of the retain sample units, can be concluded that the unit was in compliance with the manufacturing, packaging and sterilization procedures of integra. Dhr review; no anomalies were reported during the packaging and sterilization process of the reported finished goods lots that could be related to the reported condition. The fg lot 1153778 was packaged on 09/25/2015 and released for distribution on 10/15/2015. The expiration date of this lot 1153778 is 2017-09-30. Complaints history; no similar complaints related to? Inflammation? Have been reported for the fg lots 1153778. (b)(4). Conclusion: based on the investigation findings the reported condition? Inflammation? Could not be confirmed since the manufacturing and sterilization process of the lot ran normally and the finished good results were within the specification. No assignable causes and/or anomalies associated to the manufacturing, packaging and sterilization process of the reported fg lot that could contribute and/or be related with the reported condition were identified. No signs of deterioration or anomalies in the seal area of the retain samples were observed. No assignable cause was identified at this time, therefore the root cause for the reported condition could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003418325-2017-00006 |
| MDR Report Key | 6358483 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-07 |
| Date Mfgr Received | 2017-03-09 |
| Date Added to Maude | 2017-02-24 |
| 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 | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAWRAP NERVE PROTECTOR 5MM ID X 4CM LENGTH |
| Generic Name | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2017-02-24 |
| Catalog Number | NW540 |
| Lot Number | 1153778 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-24 |