MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-20 for DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS 393.103 manufactured by Synthes (usa) Brandywine.
[3710866]
It was reported that during surgery, the quick coupling for drill bits would not lock the drill bits. The quick coupling for drill bits was being used for a market preference evaluation. The shank pin was placed into the patients calcaneus for reduction control using a 393. 103 pin driving adaptor, inserted into a 530. 750 quick connect for drill bits. The driving adaptor had some damage on the quick connect shank. This may have contributed to the complaint event. There were no delays in the surgery due to this event. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11071487]
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. Investigation could not be completed and no conclusion could be drawn as no device was returned. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[26367835]
Device is used for treatment, not diagnosis. The dhr was reviewed and no issues were found during manufacture that would contribute to this complaint condition.
Patient Sequence No: 1, Text Type: N, H10
[34233191]
Device was used for treatment, not diagnosis. A service history of the past six months from the awareness date has been reviewed. No service history review can be performed. The item has not been sent in for service. There is no information relevant to the current complained issue. Changed name to (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-04882 |
| MDR Report Key | 3298983 |
| Report Source | 05,07 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-07-23 |
| Date Mfgr Received | 2014-05-12 |
| Device Manufacturer Date | 2006-10-06 |
| Date Added to Maude | 2013-11-15 |
| 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 |
| Manufacturer G1 | SYNTHES (USA) BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS |
| Product Code | GFC |
| Date Received | 2013-08-20 |
| Catalog Number | 393.103 |
| Lot Number | 5345207 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER PA 19380 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-20 |