MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-08-16 for SCREW, BIO-INTERFERENCE W/DISPOSABLE SHEATH AR-1390B manufactured by Arthrex, Inc..
[17113826]
Approximately 2. 5 yrs post-op (acl reconstruction) pt hyperflexed and twisted knee. Pt experienced complete locking. Initial arthroscopy performed in 2004, after mri findings. A "small meniscal tear with small bucket handle fragment" was excised. No evidence of any loose screw but mild grade ii chondromalacia observed in related areas (consistent with edge). The acl graft was intact and the previously screw placed no longer present. Screw holes had fibrosed (ossified). Pt. Did well for several weeks but then started having locking again. Dr. Felt something loose. On revision surgery (2004) surgeon removed "the head" of the partially absorbed bio-implant. Explanted implant has been kept by pt. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2004-00068 |
| MDR Report Key | 539034 |
| Report Source | 05,07 |
| Date Received | 2004-08-16 |
| Date of Report | 2004-08-16 |
| Date of Event | 2004-06-25 |
| Date Mfgr Received | 2004-07-30 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2004-08-17 |
| 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 | 0 |
| Manufacturer Contact | IVETTE SOTOMAYOR, MDR COORD |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW, BIO-INTERFERENCE W/DISPOSABLE SHEATH |
| Generic Name | BIO-ABSORBABLE FIXATION DEVICE |
| Product Code | MBJ |
| Date Received | 2004-08-16 |
| Model Number | AR-1390B |
| Catalog Number | AR-1390B |
| Lot Number | 25391 |
| ID Number | NA |
| Device Expiration Date | 2003-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 528329 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Baseline Brand Name | SCREW, BIO-INTERFERENCE W/DISPOSABLE SHEATH |
| Baseline Generic Name | BIO-ABSORBABLE FIXATION DEVICE |
| Baseline Model No | AR-1390B |
| Baseline Catalog No | AR-1390B |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-08-16 |