MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL 03.130.270 manufactured by Oberdorf Synthes Produktions Gmbh.
[120388406]
There was no known reported patient involvement associated with the complained event. It is unknown when device malfunctioned. Device is an instrument and is not implanted/explanted. Reporter is synthes employee. A device history record (dhr) review was conducted for part number: 03. 130. 270, synthes lot number: t117927: release to warehouse date: 09-sep-2015, manufacture site: (b)(4), part expiration date: n/a, list of nonconformance? S: n/a: a review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition for this device. The raw material certificate was reviewed, and the used material was according to the specification. No ncrs were generated during the production of this device. Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A product investigation was conducted. The broken part was sent to manufacturing site for evaluation. Visual inspection: the device appears to be in good condition before the head of one side it broke off. Some of the weld protection points are broken. At the bottom of the cutting mold is damaged on the cutting edge. Functional test: it can be confirmed that the device is broken. Drawing/specification review: the manufactured and current revisions of the drawing were reviewed and no relevant design changes were identified. Dimensional inspection: the relevant features measured are in specification. Material or hardness review: the review of the manufacturing records confirm that the used material and the hardness of the subcomponent (b)(4) during the production was according to the specification of the device. Conclusion: the manufacturing evaluation conducted shows that there was no issue during the manufacture of the product that would contribute to this complaint condition. No manufacturing issue was found during investigation, therefore no prm documents were reviewed. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[120388407]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a plate cutter was found broken by the distributor. There was no patient involvement reported. This report is for one (1) plate cutter/in-line for 1. 3mm lckng/1. 5-2. 0mm val pl. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-56284 |
| MDR Report Key | 7870162 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-07-20 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2018-09-12 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL |
| Generic Name | PLIERS, SURGICAL |
| Product Code | HTC |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-08-06 |
| Catalog Number | 03.130.270 |
| Lot Number | T117927 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |