MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-02-23 for CONTAINER ?1.6 L150 308.206 manufactured by Synthes Usa.
[5516284]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the blue end caps of the k-wire containers broke after repeated sterilization during the cleaning process. This report is 2 of 6 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12792927]
Device was used for treatment, not diagnosis. This report is for one unknown k-wire container? 1. 6 l150/unknown lot number. Not implanted/explanted. (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[31216759]
An investigation was performed; the investigation of the returned containers for k-wires has confirmed that one or more lips are broken off. The containers are made of polyphenylene sulfone (ppsu) and should resist several thousand sterilization cycles. However, it should be noted that the resistance of ppsu becomes very restricted due to combinations of chemical, thermal and mechanical loads. Thus it is known that contact with some rinse aid can lead to stress cracking. Therefore; the use of a rinse aid, whose compatibility with polyphenylene sulfone is guaranteed by the supplier. As no product fault could be detected, no further action required. 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
[32669914]
Subject device has been received and is currently in the evaluation process. 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
| Report Number | 2520274-2015-11098 |
| MDR Report Key | 4537110 |
| Report Source | 01,05,07 |
| Date Received | 2015-02-23 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2015-03-23 |
| Date Added to Maude | 2015-02-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTAINER ?1.6 L150 |
| Generic Name | WIRE,FIXATION,INTRAOSSEOUS |
| Product Code | DZK |
| Date Received | 2015-02-23 |
| Returned To Mfg | 2015-02-19 |
| Catalog Number | 308.206 |
| 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 USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-23 |