MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-19 for L. MED AGGR BLADE (31MMX9MM)S 2296003225 manufactured by Stryker Instruments-kalamazoo.
[184455893]
A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[184455894]
It was reported that during an osteotomy surgery, the blade broke at the mount. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[188145461]
The reported product involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed. The bend / twist present in the blade suggests that it was subjected to an excessive bending force or torque. This bending force / torque is the most likely cause of the mount break. The shock loading caused by metal contact could have also contributed to the blade failure. The bending forces could have occurred by pushing the headpiece forward, pulling it backwards or twisting the headpiece while the end of the blade was engaged or held. The instruction for use (ifu) for the handpieces associated for use with this blade contain the following indication for use "when used with a variety of cutting accessories, the remb electric sagittal saw is intended for surgical procedures involving the cutting of bone and hard tissue. " the ifu's also contain the following warning; "do not apply excessive pressure, such as bending or prying, with the blade. Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control. "
Patient Sequence No: 1, Text Type: N, H10
[188145462]
It was reported that during an osteotomy surgery, the blade broke at the mount. It was also reported there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00714 |
| MDR Report Key | 9855820 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L. MED AGGR BLADE (31MMX9MM)S |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL |
| Product Code | GFA |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 2296003225 |
| Catalog Number | 2296003225 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |