MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-19 for 4.9MM HEALX ADV SP BIOC ANCHOR 222422 manufactured by Medos International Sàrl.
[188652051]
Product complaint #: (b)(4). 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188652052]
It was reported by the sales rep via phone that during a arthroscopic shoulder stabilization procedure shortly after the 4. 9mm healix adv sp biocomposite anchor was inserted , the tape lost all tension. The physician was able to remove the suture from the cuff/anchor while the anchor remained in the bone. Another device was used to complete the procedure. No patient consequences or surgical delay reported. The device was discarded by the hospital. No replacement was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00921 |
| MDR Report Key | 9856912 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-29 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-03-19 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT MITEK |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.9MM HEALX ADV SP BIOC ANCHOR |
| Generic Name | SOFT-TISSUE ANCHOR, BIOABSORBABLE |
| Product Code | MAI |
| Date Received | 2020-03-19 |
| Model Number | 222422 |
| Catalog Number | 222422 |
| Lot Number | 5L93076 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |