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 2014-03-07 for IN-SITU BENDER 03.100.090 manufactured by Synthes Tuttlingen.
[4346478]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date the tip from the bender broke. The customer doesn? T know where the fragment is and when the issue happened. No further information was reported. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11688961]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/ explanted. Investigation could not be completed and no conclusion could be drawn as no device was received. A review of the device history records was performed and no complaint related issues were found. 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
[11836227]
Device was used for treatment, not diagnosis. Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Subject device has been received and is currently in the evaluation process.
Patient Sequence No: 1, Text Type: N, H10
[20302143]
Device was used for treatment, not diagnosis. Additional narrative: an evaluation was performed on the returned device. As per received condition the device; the tip of the article broken off. The complained device has been checked according to the manufacturing and material specifications and it was determined that the requirements and specifications have been fulfilled. Based on this result manufacturing failure can be excluded. The clamp is broken and next to the break deformed also, it shows that excessive force has been applied for a short time, which has led to this damage. 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 | 3009417901-2014-10009 |
| MDR Report Key | 3666865 |
| Report Source | 01,05,07 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-10 |
| Date Mfgr Received | 2014-05-14 |
| Device Manufacturer Date | 2011-06-22 |
| Date Added to Maude | 2014-05-14 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS 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 ZENTRALER RECHNUNGSEINGANG |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN-SITU BENDER |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-03-07 |
| Returned To Mfg | 2014-02-20 |
| Catalog Number | 03.100.090 |
| Lot Number | T961806 |
| 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 TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 ZENTRALER RECHNUNGSEINGANG TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-07 |