MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[117133662]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Citation: the american journal of sports medicine, vol. 36, no. 5, doi:10. 1177/0363546507312643. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[117133663]
It was reported via journal article title : minimally invasive coracoclavicular stabilization with suture anchors for acute acromioclavicular dislocation author: sung wook choi, md, tong joo lee,md, kyoung ho moon, md, kyu jung cho, md, and seung yeol lee, md citation: the american journal of sports medicine, vol. 36, no. 5, doi:10. 1177/0363546507312643. The purpose of this study was to introduce a new operative technique for acromioclavicular (ac) dislocation that utilizes suture anchor. A total of 20 patients with a follow-up of 24 months or more were enrolled from among 26 patients with a diagnosis of ac dislocation and operated on using a suture anchor between august 2002 and may 2005. During the procedure, sutures are then placed in the torn coracoclavicular ligaments for later repair. Two corkscrew suture anchors (fastin rc anchor with no. 2 ethibond, ethicon inc, johnson and johnson, (b)(4)) are placed into the base of the coracoid process following the previously placed guide pins. Each suture anchor is connected to 2 strands of no. 5 non-absorbable braided suture (ethicon). Next the clavicle is prepared, and 2 holes are opened through the superior cortex using a 2. 4-mm drill bit placed in the center of the clavicle, approximately 2. 5 cm and 3. 5 cm proximal to its distal end, respectively, while ensuring that the holes are at the anatomical origins of the conoid and trapezoid ligaments. A suture passer is then passed through the holes from superior to inferior to capture and shuttle 1 limb of each suture through its corresponding hole. One limb of the lateral suture anchor is used later for the anterior retention of the clavicle, and 1 limb of the medial suture anchor is passed behind the clavicle as close as possible to the inferior border of the distal clavicle. Finally, the clavicle is held with a reduction clamp and reduced with upward displacement of the scapulohumeral complex by an assistant under intensifier guidance. The surgeon holds the 1 pair of each suture in opposite directions, anteriorly and posteriorly, which enables correction of the horizontal and vertical displacement of the clavicle, while the assistant reduces the dislocated clavicle with the reduction clamp. Alternatively, both limbs of the 2 suture anchorscan be passed through their corresponding hole and tied over the bone bridge. The sutures placed in coracoclavicular ligaments earlier are then tied. One patient developed a superficial soft-tissue infection that was easily managed with oral antibiotics. No vascular or neurological complications occurred. In conclusion, the developed surgical technique based on the use of a suture anchor for acute-stage ac joint dislocation is minimally invasive. The required operative technique is relatively simple, can potentially reduce surgical time, and allows optimal coracoclavicular ligament reconstruction. Acromioclavicular joint reduction with horizontal and vertical stability is achieved by precisely placing 1 pair of sutures in the anatomic position of the disrupted coracoclavicular ligament complex. The placing of 2 suture anchors accurately at the base of the coracoid process also enables early shoulder joint motion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-75158 |
| MDR Report Key | 7783062 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-08-14 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC |
| Product Code | GAK |
| Date Received | 2018-08-14 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-14 |