MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-29 for FIBRE OPTIC CABLE F/LIGHT STRIP 03.612.031 manufactured by Synthes Monument.
[15013935]
Device report from synthes (b)(6) reports an event in (b)(6) as follows: the rubber area of the cable that is used to pull the cable in and out of the light source, broke when being pulled while the surgery ended. The cable was used and functioned perfectly throughout the surgery. It broke when being taken for cleaning. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15279260]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn.
Patient Sequence No: 1, Text Type: N, H10
[28392951]
(b)(4): review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[33871436]
A manufacturing evaluation was conducted and it states that the part was received with a tear on the over-molded strain relief on the etched connector. The part was inspected for the integrity of the attachment of the over-molded metal end to the fiber optic cable upon receipt. This is a manual inspection, but the sample passed. An inspection of the complaint device indicates that the over-molded ends are still well attached to the cable. The inspection also includes a 100 percent visual inspection for cosmetics. Based on the specifications at the time of the original manufacturing, the unknown root cause, and the evaluation performed by synthes, this complaint is deemed indeterminate from a manufacturing position.
Patient Sequence No: 1, Text Type: N, H10
[33871437]
This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2013-01843 |
| MDR Report Key | 3251274 |
| Report Source | 01,07 |
| Date Received | 2013-07-29 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-06-29 |
| Date Mfgr Received | 2013-10-01 |
| Device Manufacturer Date | 2011-01-12 |
| Date Added to Maude | 2013-10-23 |
| 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 | W. LINDENMUTH |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBRE OPTIC CABLE F/LIGHT STRIP |
| Product Code | FDG |
| Date Received | 2013-07-29 |
| Returned To Mfg | 2013-07-11 |
| Catalog Number | 03.612.031 |
| Lot Number | 6484241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-29 |