MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2007-05-11 for 8MM SINGLE USE OATS SET AR-1981-08S manufactured by Arthrex, Inc..
[646018]
It was reported that the recipient piece broke during the harvesting of the recipient socket, 20mm from the end, just above the window. The procedure was normal. The recipient has been used multiple times. The recipient broke during the third time. The broken piece remains in the pt. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[7965468]
Eval confirmed the recipient harvester broke at the 20mm laser marking. Material verification was performed and found within specifications. This product is a single use osteochondral autograft transfer system. The original info provided indicates the device was used multiple times. However, no clarification could be obtained from the customer, as if the device was used several times during the same surgery or during different surgeries. This is the first complaint of this type for this product. A definitive conclusion could not be determined from the info provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2007-00078 |
| MDR Report Key | 851331 |
| Report Source | 01,08 |
| Date Received | 2007-05-11 |
| Date of Report | 2007-05-10 |
| Date of Event | 2007-01-01 |
| Date Mfgr Received | 2007-04-16 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-08-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | IVETTE GALMEZ, SR. ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BLVD. |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8MM SINGLE USE OATS SET |
| Generic Name | HARVESTING TOOLS |
| Product Code | GFI |
| Date Received | 2007-05-11 |
| Returned To Mfg | 2007-04-30 |
| Model Number | NA |
| Catalog Number | AR-1981-08S |
| Lot Number | 06124 |
| ID Number | NA |
| Device Expiration Date | 2011-09-01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 838394 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-11 |