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 |