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 2020-03-13 for 4.9MM HEALX ADV SP BIOC ANCHOR 222422 manufactured by Medos International Sàrl.
[188647606]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188647607]
It was reported by the sales rep via phone that during a rotator cuff repair the tip of the 4. 9mm healx adv sp biocryl anchor fell off. All the fragments have been retrieved from the patient? S body. However a new bone hole had to be created to use a new device to complete the procedure. 2 minutes delay reported. No patient consequences. The device is available to be returned for evaluation. No replacements needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00849 |
| MDR Report Key | 9831556 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-13 |
| 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, NON-BIOABSORBABLE |
| Product Code | JDR |
| Date Received | 2020-03-13 |
| Model Number | 222422 |
| Catalog Number | 222422 |
| Lot Number | 5L93075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-13 |