MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for BLOCKER HOLDER 046W1AN00590 manufactured by Zimmer Spine.
[66334385]
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
[66334386]
It was reported that the blocker holder broke while being used to tighten a blocker. A second blocker holder was used to complete the surgery. There were no pieces which fell into the patient. There were no reports of patient injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[79072954]
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. The labeling was reviewed and found to contain instructions regarding proper device usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003853072-2017-00009 |
| MDR Report Key | 6286035 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-06-19 |
| Date of Event | 2016-12-27 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2015-04-07 |
| Date Added to Maude | 2017-01-30 |
| 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. TERESA GEORGE |
| Manufacturer Street | 310 INTERLOCKEN PKWY STE. 120 NA |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER SPINE |
| Manufacturer Street | 23 PARVIS DES CHARTRONS CITE MONDIALE |
| Manufacturer City | BORDEAUX, CEDEX 33080 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOCKER HOLDER |
| Generic Name | STARTER, SCREW/SET SCREW |
| Product Code | HWD |
| Date Received | 2017-01-30 |
| Model Number | NA |
| Catalog Number | 046W1AN00590 |
| Lot Number | A2108804A |
| ID Number | (01)00889024342170 |
| 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 SPINE |
| Manufacturer Address | 23 PARVIS DES CHARTRONS CITE MONDIALE BORDEAUX, CEDEX 33080 FR 33080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-30 |