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 2018-03-26 for GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..
[103420753]
(b)(4). Concomitant medical products: 00249003200, impaction head, unknown; 00249000300, cephalomedullary targeting guide standard, unknown. Report source, foreign - the event occurred in (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01747, 0001822565 - 2018 - 01746.
Patient Sequence No: 1, Text Type: N, H10
[103420754]
It was reported that the items broke during an im nailing procedure. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[132603328]
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number. This event will be reported on 0001822565-2018-03977.
Patient Sequence No: 1, Text Type: N, H10
[132603329]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-01748 |
| MDR Report Key | 7369082 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-03-26 |
| Date of Report | 2018-08-02 |
| Date Mfgr Received | 2018-07-03 |
| Device Manufacturer Date | 2010-07-13 |
| Date Added to Maude | 2018-03-26 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDE WIRE GRIPPER |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2018-03-26 |
| Returned To Mfg | 2018-04-24 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 61571814 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |