MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-07 for TRS SAW HAND PIECE manufactured by Synthes (usa).
[10469279]
Additional narrative:device used for treatment and not diagnosis:additional information. (b)(4): manufacturing documents were reviewed and no complaint related issues were found. The product was received and the investigation is ongoing. (b)(4): placeholder.
Patient Sequence No: 1, Text Type: N, H10
[10474237]
Additional narrative:device used for treatment and not diagnosis. Investigation is ongoing. (b)(4): placeholder.
Patient Sequence No: 1, Text Type: N, H10
[10675100]
Device used for treatment and not diagnosis. According the investigation of the two handpieces and the attachments it can be said that the hand piece are not the problem. The problem is the grease emission in the rear part of several attachments. Regarding the different attachments, at the present time it can not be said which attachments are affected from this grease emission. But a risk assessment is currently pending.
Patient Sequence No: 1, Text Type: N, H10
[16598113]
A device report from synthes (b)(4) provides info from a facility in (b)(6) regarding an unidentifiable white film that was discovered on two trs saw hand pieces following washing and sterilization that was reportedly conducted according to the instructions provided by synthes. Upon opening each of the sets, a white film was discovered on the hand pieces.
Patient Sequence No: 1, Text Type: D, B5
[16621541]
An investigation and device history records review could not be completed and no conclusion could be drawn as no part or lot number was provided and the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-03721 |
| MDR Report Key | 2915097 |
| Report Source | 01,07 |
| Date Received | 2012-12-07 |
| Date of Report | 2012-11-09 |
| Date of Event | 2012-11-09 |
| Date Mfgr Received | 2013-03-18 |
| Date Added to Maude | 2013-03-13 |
| 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 | SHERRY LAING |
| Manufacturer Street | 1690 RUSSELL RD. |
| Manufacturer City | PAOLI PA 19301 |
| Manufacturer Country | US |
| Manufacturer Postal | 19301 |
| Manufacturer Phone | 1800627025 |
| Manufacturer G1 | SYNTHES (USA) |
| Manufacturer Street | 1690 RUSSELL RD. |
| Manufacturer City | PAOLI PA 19301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRS SAW HAND PIECE |
| Generic Name | SAW HAND PIECE |
| Product Code | HSO |
| Date Received | 2012-12-07 |
| Returned To Mfg | 2013-01-14 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL RD. WEST CHESTER PA 19301 US 19301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-07 |