MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-17 for IDEAL SUTGRASPER 60 DEG *EA 251723 manufactured by Depuy Mitek Llc Us.
[188645748]
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
[188645749]
It was reported by affiliate via personal interaction that during procedure the surgeon retracted the ideal sutgrasper 60 deg ea. In closed position out of the joint, then the wire broke and was lost. The procedure was completed with 30 minute delay. No patient consequences reported. The device is available to be returned for evaluation. Additional information provided by the affiliate reported the broken wire was a part of the grasper and not the implant. It was also reported the broken wire was possibly left in the patient and additional information regarding the status of the patient could not be provided. The affiliate reported the device will not be returning for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00875 |
| MDR Report Key | 9842609 |
| Report Source | FOREIGN |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-08-09 |
| Date Added to Maude | 2020-03-17 |
| 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 | IDEAL SUTGRASPER 60 DEG *EA |
| Generic Name | SUTURE/NEEDLE PASSER, REUSABLE |
| Product Code | NBH |
| Date Received | 2020-03-17 |
| Model Number | 251723 |
| Catalog Number | 251723 |
| Lot Number | 5L45473 |
| 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 | 2020-03-17 |