MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-09-19 for HAMMER 700 GRAMS 399,43 manufactured by Synthes Gmbh.
[2906463]
During a dhs procedure, the surgeon gave a gentle tap to the mallet and it fell apart. The surgeon used another instrument to complete the procedure. There was no adverse event to the pt.
Patient Sequence No: 1, Text Type: D, B5
[10152009]
Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. Synthes (b)(4) was not able to complete the device history records review because the part is approx 8 years old and cannot be found in the archive system.
Patient Sequence No: 1, Text Type: N, H10
[10402787]
The returned hammer was received in 2 pieces. The handle with shaft and the hammer head. The hammer head has the dowel pin still intact and secured inside the hammer head and the very tip portion of the shaft trapped by the dowel pin. The shear occurred to the shaft at the midpoint of the interface with the dowel pin. The shaft material at the shear point is homogeneous. Several dents and scratches exist on the hammer head. The returned hammer is almost 8 years old and shows noticeable wear from repeated use. The low complaint rate for this complaint issue confirms that the design is adequate for the intended use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-00867 |
| MDR Report Key | 2759371 |
| Report Source | 05,07 |
| Date Received | 2012-09-19 |
| Date of Report | 2012-08-22 |
| Date of Event | 2012-08-22 |
| Date Mfgr Received | 2012-10-10 |
| Device Manufacturer Date | 2004-11-29 |
| Date Added to Maude | 2013-01-09 |
| 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 | SARMA PIN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF CH-4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAMMER 700 GRAMS |
| Generic Name | HAMMER 700 GRAMS |
| Product Code | HXL |
| Date Received | 2012-09-19 |
| Returned To Mfg | 2012-09-07 |
| Catalog Number | 399,43 |
| Lot Number | A7NA44 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-19 |