MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for LUPINE BR DS W/ORTHCRD 210712 manufactured by Depuy Mitek Llc Us.
[188648334]
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
[188648335]
It was reported by the sales rep via complaint submission tool that during a labral repair when using lupine br ds w/orthcrd, after drilling and inserting the anchor and beginning to tie de knots, the surgeon noticed that the anchor had pulled out of the bone and he had to remove it. Another lupine br ds w/orthcrd was opened and the surgeon attempted to place it very closely to the original bone hole even though he redrill. Again the same issue occurred with the anchor pulling out of the bone. The patients bone was suspect but he was upset. The case was successfully completed using another unit. No patient consequence, however there was a 10 minutes surgical delay reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00777 |
| MDR Report Key | 9801938 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-06 |
| 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 | LUPINE BR DS W/ORTHCRD |
| Generic Name | SOFT-TISSUE ANCHOR, BIOABSORBABLE |
| Product Code | MAI |
| Date Received | 2020-03-06 |
| Model Number | 210712 |
| Catalog Number | 210712 |
| Lot Number | 6L44914 |
| 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 | 2020-03-06 |