MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-18 for 4.75 HEALIX ADVANCE KNTLSS BR 222330 manufactured by Depuy Mitek Llc Us.
[188655600]
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
[188655601]
It was reported by the affiliate that during an arthroscopic rotator cuff repair the tip of the 4. 75 healix advance kntlss br broke off during the insertion. The procedure was completed using a replacement, however the surgeon had to create a new burr hole. No fragments were left in the patient's body. No surgical delay was reported. No additional information was provided. Additional information provided by the affiliate reported the device will not be returning for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00906 |
| MDR Report Key | 9850282 |
| Report Source | FOREIGN |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-31 |
| Date Added to Maude | 2020-03-18 |
| 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 | 4.75 HEALIX ADVANCE KNTLSS BR |
| Generic Name | SOFT-TISSUE ANCHOR, BIOABSORBABLE |
| Product Code | MAI |
| Date Received | 2020-03-18 |
| Model Number | 222330 |
| Catalog Number | 222330 |
| Lot Number | 3L68946 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |