MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-15 for COUNTERSINK manufactured by Synthes Usa.
[52169652]
Device was used for treatment, not diagnosis. Arthroscopic reconstruction of the anterior cruciate ligament with patellar-tendon autograft and interference screw fixation. The journal of bone and joint surgery. (1999) 81-b: 775 to 779. This report is for unknown screw /unknown quantity/ unknown lot. The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[52169653]
This report is being filed after the subsequent review of the following literature article: jomha, n. M. , pinczewski, a. L. , clingeleffer, a. , otto, d. D. (1999). Arthroscopic reconstruction of the anterior cruciate ligament with patellar-tendon autograft and interference screw fixation. The journal of bone and joint surgery. 81-b: 775 to 779, australia. This article provides a discussion involving 59 patients who had undergone an arthroscopic reconstruction of the anterior cruciate ligament (acl) using a central-third patellar-tendon autograft for seven years. In all operations, the same technique was used, which involved a central-third patellar-tendon autograft with bone blocks taken from the ipsilateral knee and inserted through holes drilled in the tibia and femur. Ao 6. 5 mm fully threaded cancellous screws achieved interference fixation. Where there was abnormal medial collateral ligament (mcl) laxity, the proximal ligament was advanced just before fixation of the acl graft to the tibia, and fixed with a staple. Post-operatively, patients were infused intravenously with antibiotics for 24 hours and knees were subjected to continuous passive motion from 30 degrees to 90 degrees for 48 hours. Patients were also non-weight bearing in a rehabilitation brace (30 degrees to 90 degrees) for four weeks. Wound inspection occurred daily and sutures were removed 10 to 14 days after surgery. Additional follow-ups were performed up to 7 years. Complications: screws were removed in seven cases and one reported post-operative infection (treated by lavage and removal of screw). This is report 1 of 1 for (b)(4). This report is for an unknown ao screw.
Patient Sequence No: 1, Text Type: D, B5
[54043119]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-14101 |
| MDR Report Key | 5877578 |
| Date Received | 2016-08-15 |
| Date of Report | 2016-07-29 |
| Date Mfgr Received | 2016-08-16 |
| Date Added to Maude | 2016-08-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | COUNTERSINK |
| Product Code | HWW |
| Date Received | 2016-08-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-15 |