MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for BASE PLATE DRILL GUIDE 1 N/A 00430904300 manufactured by Zimmer Biomet, Inc..
[111917776]
(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: 0001822565-2018-03297.
Patient Sequence No: 1, Text Type: N, H10
[111917777]
It was reported that during a shoulder procedure, the guide pin was stuck in the guide. Another same instrument was used to complete the procedure. No harm to the patient or delay in procedure was noted. Attempts to obtain additional information have been made; however, no more is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[132274177]
The follow up report is being submitted to relay additional information update: the complaint cannot be confirmed as no medical records or pictures were provided. Device history records cannot be reviewed since the lot number is unknown. A definite root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[132274178]
It was reported that during a shoulder procedure, the guide pin was stuck in the guide. Another same instrument was used to complete the procedure. No harm to the patient or delay in procedure was noted. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03296 |
| MDR Report Key | 7609665 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-09-20 |
| Date Added to Maude | 2018-06-18 |
| 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 | 0 |
| Brand Name | BASE PLATE DRILL GUIDE 1 |
| Generic Name | SHOULDER, INSTRUMENT |
| Product Code | MJT |
| Date Received | 2018-06-18 |
| Model Number | N/A |
| Catalog Number | 00430904300 |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2018-06-18 |