MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-11-14 for SOLITAIRE TI 25MM U-JOINT AWL N/A 1400-9133 manufactured by Zimmer Biomet Spine.
[59791196]
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
[59791197]
It was reported that during surgery, the depth stop ring of a u-joint awl broke off and fell into the wound. It was promptly removed so the patient did not retain a foreign body. A different instrument was used to complete the procedure. There was a 30 minute delay to the procedure to remove the broken piece, but there were no reports of patient injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[77019870]
The device was not returned for evaluation. A review of the manufacturing records did not identify any issues which would have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004485144-2016-00310 |
| MDR Report Key | 6099811 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-11-14 |
| Date of Report | 2017-06-02 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2017-05-24 |
| Device Manufacturer Date | 2009-09-29 |
| Date Added to Maude | 2016-11-14 |
| 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 | MR. GEOFFREY GANNON |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLITAIRE TI 25MM U-JOINT AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-11-14 |
| Model Number | N/A |
| Catalog Number | 1400-9133 |
| Lot Number | PR27E |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |