MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-16 for CETERIX DISPOSABLE SUTURE PASSER CTX-A100 manufactured by Ceterix Orthopaedics.
[6016222]
After a (b)(6) 2015 procedure using the ceterix suture passer, the patient experienced knee pain, swelling and a catching sensation when going down stairs. The surgeon ordered an x-ray, where a small metal fragment was found. A subsequent procedure on (b)(6) 2015 was performed to remove the metal fragment.
Patient Sequence No: 1, Text Type: D, B5
[14381347]
The initial complaint was received by ceterix on (b)(6) 2015 where it was reported that during this surgery, ceterix disposable suture passer lot # m140157 had an upper jaw break. Ceterix disposable suture passer lot # m140157 was returned to ceterix for investigation. Visual inspection of the returned device confirmed the upper jaw break. Functional testing was performed and all specifications and functional testing was performed and all specifications and functional requirements that could be tested with the upper jaw missing were met. A lot history review was also performed, and no manufacturing related issues were identified which would affect the device functionality during use. Probable root cause of the upper jaw break was determined to be excessive torque used during device application. The ifu warns against forcing the device into tight spaces and that excessive pushing, twisting or levering may cause breakage. After the metal fragment was removed from the patients knee, it was returned to ceterix for evaluation. Analysis confirmed that the fragment was likely to have come from the upper jaw pin/hinge of the previously investigated ceterix disposable suture passer lot # m140157. A review of complaints was performed, and no other cases of jaw pin/hinge fragments being found post op were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009131204-2015-00004 |
| MDR Report Key | 4924216 |
| Report Source | 05 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2015-06-22 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-07-21 |
| 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 | 0 |
| Manufacturer Contact | DANIELLA ORTIZ-FELIX |
| Manufacturer Street | 959 HAMILTON AVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6502411748 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CETERIX DISPOSABLE SUTURE PASSER |
| Generic Name | SUTURE PASSER |
| Product Code | LHX |
| Date Received | 2015-07-16 |
| Returned To Mfg | 2015-04-21 |
| Model Number | CTX-A100 |
| Lot Number | M140157 |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CETERIX ORTHOPAEDICS |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-16 |