MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-05-01 for DISPOSABLE MIXING BOWLS WITH SPATULA 00-5049-011-00 manufactured by Zimmer Surgical.
[5891174]
It was reported that a foreign material got mixed within the packaging of the spatula. Additional info obtained indicated that the reported contaminated product entered the sterile field. The customer used and finished the surgery with an alternative one. There was no patient harm or delays reported.
Patient Sequence No: 1, Text Type: D, B5
[13438556]
The device was not returned to the mfr at the time of this report. A f/u medwatch will be submitted, once the device has been returned and the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[51162087]
The device was returned on 05/20/2015 in a plastic zip lock bag. The spatula and pouch and the mixing bowl were returned. The contamination was captured and saved on two sticky tabs and was inside the spatula pouch. No obvious damage was visible with the returned product. The evaluation of the contamination that was returned with the device appears to be plastic - most probably flashing from the spatula. This evaluation was accomplished using a digital electronic microscope. The customers reported event was foreign material was found inside the pouch of the spatula. The information provided and the returned product confirm that contaminant was found by the customer. The review of the device history record (dhr) noted no non-conformances. Requests for deviation (rpd's) or other issues. The quality records show that this lot was prepared in accordance with the requirements of the quality management system and all the quality control tests were passed successfully. Additionally, the review of the manufacturing process noted no systemic issues. The particulate is larger than the allowable size according to the procedure. The most likely cause for this contamination is flashing on the spatula was sloughed off and captured in the sealed pouch during handling and transit after packaging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526350-2015-00085 |
| MDR Report Key | 4751470 |
| Report Source | 01,07 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-01 |
| Date Added to Maude | 2015-06-11 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHLEEN SMITH |
| Manufacturer Street | 200 WEST OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE MIXING BOWLS WITH SPATULA |
| Generic Name | DISPOSABLE MIXING BOWLS WITH SPATULA |
| Product Code | GAF |
| Date Received | 2015-05-01 |
| Returned To Mfg | 2015-05-20 |
| Model Number | NA |
| Catalog Number | 00-5049-011-00 |
| Lot Number | 62735851 |
| ID Number | NA |
| Device Expiration Date | 2017-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-01 |