MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2015-03-01 for GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM 232110 manufactured by Orthotech.
[5457593]
Hair found in package. Additional information from the sales rep was that the hair was loose in the package and was not opened.
Patient Sequence No: 1, Text Type: D, B5
[12936185]
Attempts have been made to retrieve additional information about the event and device. The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time. When and if additional information is received it will be reflected in a follow-up medwatch report. Awaiting return.
Patient Sequence No: 1, Text Type: N, H10
[35073985]
This is a follow up report to document device return. A final report will be filed once the device has been investigated. In process.
Patient Sequence No: 1, Text Type: N, H10
[35073986]
Hair found in package. Additional information from the sales rep was that the hair was loose in the package and was not opened.
Patient Sequence No: 1, Text Type: D, B5
[35239571]
The complaint device was received and inspected. The received device was inside its sterile packaging and there was a small strand of hair found in the outer plastic packaging, confirming this complaint. A batch record review has been conducted to determine if there were any internal processing issues that would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. It is possible that this failure occurred during packaging. We believe this to be anomaly and a one off incident. Based on the overall complaint rates for this type of failure across all product families, at this point in time, no corrective action is required and no further action is warranted. However, mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Patient Sequence No: 1, Text Type: N, H10
[35239572]
Hair found in package. Additional information from the sales rep was that the hair was loose in the package and was not opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2015-00635 |
| MDR Report Key | 4556074 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2015-03-01 |
| Date of Report | 2015-01-29 |
| Date Facility Aware | 2015-01-29 |
| Report Date | 2015-01-29 |
| Date Reported to Mfgr | 2015-01-29 |
| Date Mfgr Received | 2015-01-29 |
| Device Manufacturer Date | 2014-03-10 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. ERIC SO |
| Manufacturer Street | 325 PARAMOUNT DRIVE QUALITY DEPARTMENT |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 8003824682 |
| Manufacturer G1 | DEPUY MITEK |
| Manufacturer Street | 325 PARAMOUNT DRIVE NA |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM |
| Generic Name | ACL ACCESSORIES |
| Product Code | GDX |
| Date Received | 2015-03-01 |
| Returned To Mfg | 2015-03-20 |
| Model Number | NA |
| Catalog Number | 232110 |
| Lot Number | 3759690 |
| ID Number | NA |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOTECH |
| Manufacturer Address | 60 GLACIER DRIVE QUALITY DEPARTMENT WESTWOOD MA 02090 US 02090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-01 |