MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-05-23 for CARROLL-GIRARD SCREW HEX-END N/A SP-2693 manufactured by Biomet Microfixation.
[75815406]
A photograph was provided which confirms the device is fractured. The user facility is foreign; therefore a facility medwatch report will not be available. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[75815407]
It was reported during an open reduction and internal fixation for zygomatic arch procedure a screw broke. The remaining screw was removed using a diamond bar. A surgical delay over 30 minutes was reported, however the exact delay is unknown. The patient did not retain a foreign body.
Patient Sequence No: 1, Text Type: D, B5
[81168356]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[107126846]
The product identity was confirmed in the evaluation. The product was visually evaluated and was seen to be fractured. There is a slight bend leading into the fracture sight which is expected as there was plastic deformation just prior to fully fracturing. There is tissue remaining in the threads, but the thread form is clean with the exception of the areas affected during removal with the diamond bar. The most likely cause of this is determined to be excessive force on an off axis angle while attempting to approximate tightly positioned bone fragments. Instructions for use state, "avoid undue stress or strain when handling or cleaning instruments. " the non-conformance database was reviewed and there are no non-conformances associated with this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2017-00404 |
| MDR Report Key | 6586120 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-05-23 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 2016-02-22 |
| Date Added to Maude | 2017-05-23 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARROLL-GIRARD SCREW HEX-END |
| Generic Name | CORKSCREW, ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HWI |
| Date Received | 2017-05-23 |
| Returned To Mfg | 2017-05-10 |
| Model Number | N/A |
| Catalog Number | SP-2693 |
| Lot Number | 655320 |
| ID Number | (01)00841036145491(10)655320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-23 |