MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-04 for TOWER WRIST JOINT 10100014 manufactured by Acumed Llc.
[134896041]
Returned product examined visually under magnification. All threaded features were inspected and found to be in good condition. Welds connecting the arm sleeves to the locking joint have cracked. Additional mdrs associated with this event: 3025141-2019-00097: rosette knob 1, 3025141-2019-00098: rosette knob 2, 3025141-2019-00100: tower upper arc.
Patient Sequence No: 1, Text Type: N, H10
[134896042]
During surgery on the patient's arm, it was supported by the arc wrist tower. During the surgery, the surgeon found tiny metal flakes in the wound. The flakes were coming from the arc wrist tower. All of the metal flakes were not successfully removed from the wound, as some were sticking to the synovium even when washed thoroughly. There was a delay in surgery as a result of this situation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3025141-2019-00099 |
| MDR Report Key | 8301468 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-10 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-01-15 |
| Date Added to Maude | 2019-02-04 |
| 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 | MS. MICKI ANDERSON |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal | 97124 |
| Manufacturer Phone | 8886279957 |
| Manufacturer G1 | ACUMED LLC |
| Manufacturer Street | 5885 NE CORNELIUS PASS ROAD |
| Manufacturer City | HILLSBORO OR 97124 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOWER WRIST JOINT |
| Generic Name | APPARATUS, TRACTION, NON-POWERED |
| Product Code | HST |
| Date Received | 2019-02-04 |
| Returned To Mfg | 2019-01-14 |
| Model Number | 10100014 |
| Catalog Number | 10100014 |
| Lot Number | 364026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUMED LLC |
| Manufacturer Address | 5885 NE CORNELIUS PASS ROAD HILLSBORO OR 97124 US 97124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-04 |