MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for UNKNOWN GUIDE PIN N/A manufactured by Zimmer Biomet, Inc..
[109994866]
(b)(4). Catalog #00430904300, base plate drill guide 1, lot # unknown. (b)(6). 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: 0001822565-2018-03019.
Patient Sequence No: 1, Text Type: N, H10
[109994867]
It was reported that during a workshop before a shoulder arthroplasty surgery, the surgeon tried moving the pin through the drill guide but was unable to do so. The pin became stuck inside the guide. The surgery was completed using a different device. No patient impact was reported, as there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[133760657]
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Visual inspection shows scratches and dings along the surface likely from prior use. This item has a piece of an unknown pin seized inside of the hole. The returned items do not contain an etch so identification cannot be determined. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. 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
[133760658]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03020 |
| MDR Report Key | 7562479 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-07-23 |
| Date Added to Maude | 2018-06-01 |
| 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 | UNKNOWN GUIDE PIN |
| Generic Name | INSTRUMENT, SHOULDER |
| Product Code | MJT |
| Date Received | 2018-06-01 |
| Model Number | N/A |
| Catalog Number | NI |
| 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 | 2018-06-01 |