MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-24 for AO REDUCTION DRIVE UNIT 532.017 manufactured by Synthes Usa.
[3742206]
Facility reported that ao reduction drive unit broke in two pieces. No injury to the patient was reported. This report is 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11084866]
Device is used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The reporter's complaint of unit broke in two pieces was confirmed. The device was evaluated and the complaint was duplicated. Evidence indicates this is due to improper handling. The manufacturing documents were reviewed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[28943723]
Device was used for treatment, not diagnosis. Service history of the past six months from the awareness date was reviewed. No service history review can be performed. The item has not been in for service for the past six months. There is no information relevant to the current complained issue. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-06508 |
| MDR Report Key | 3365422 |
| Report Source | 05 |
| Date Received | 2013-09-24 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-27 |
| Date Mfgr Received | 2014-05-19 |
| Device Manufacturer Date | 2009-09-09 |
| Date Added to Maude | 2014-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AO REDUCTION DRIVE UNIT |
| Product Code | GFC |
| Date Received | 2013-09-24 |
| Returned To Mfg | 2013-09-06 |
| Catalog Number | 532.017 |
| Lot Number | MA1061 |
| 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 | WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-24 |