MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-03-21 for SLOTTED MALLET PDL102 manufactured by Synthes Gmbh.
[3193019]
It was reported that during an l4-s1 alif, the plastic end of the mallet broke off. All broken pieces retrieved. Another mallet was used to complete the procedure. During the same procedure, the clamp kept slipping off from the side of the synframe. Another set of clamps were used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[3740116]
This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10556070]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of the device history records was performed and no complaint related issues were found. The product development evaluation revealed that the mallet appears to be well worn, with dents and scratches all over the metallic and plastic impaction surfaces, as well as the slotted impact surface. The plastic impaction cap on the mallet head is broken where it necks down to thread into the mallet head. The remaining threaded portion of the impaction cap is still threaded into the mallet head. When the broken plastic impaction surface is matched to the remaining threaded piece, there appears to be a gap from the flat surface of the impaction cap to the mallet head, indicating it may not have been fully threaded on when it was used and fractured. The white plastic impaction cap of the mallet is intended to be used when fully threaded into the mallet. In this configuration, impaction loads are transferred and shared between the impaction surface of the plastic and the metal mallet head. If the mallet is used while the plastic head is not fully threaded on, the loads are not shared and are transferred to the smaller threaded region of the impaction cap, allowing for the chance of fracture. Given the type and location of the fracture of the impaction cap, it is likely that this mallet was used while the head was not fully threaded on. The fracture of the mallet plastic impaction cap is most likely a result of use of the instrument while it was not fully assembled. A gap between the impaction surface and metal mallet head was noted when the fractured pieces were re-aligned, but it is unclear whether this was the exact configuration of the instrument at the time of failure. Therefore, it is concluded that this complaint is indeterminate. The manufacturing evaluation showed that the plastic insert had sheared off. The mallet corresponds to the drawing and processes at the time of manufacture. It is concluded that this complaint is invalid from a manufacturing standpoint. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[11228823]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10537 |
| MDR Report Key | 3014370 |
| Report Source | 05,07 |
| Date Received | 2013-03-21 |
| Date of Report | 2012-02-05 |
| Date of Event | 2012-02-05 |
| Date Mfgr Received | 2012-02-05 |
| Device Manufacturer Date | 2006-02-03 |
| Date Added to Maude | 2013-05-22 |
| 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 | T. MCCARRON |
| 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 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLOTTED MALLET |
| Product Code | HXL |
| Date Received | 2013-03-21 |
| Returned To Mfg | 2012-03-07 |
| Catalog Number | PDL102 |
| Lot Number | A7 OA 46 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-21 |