MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for COUNTERSINK, CANNULATED AUTOFIX 2.0/2.5 9071003 manufactured by Stryker Gmbh.
[28834115]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[28834116]
Or manager reported the following event, during a procedure, the device fractured and a metal fragment was left inside the patients' bone. The contact person called and the procedure was still ongoing. The surgeon was trying to extract/ remove the fragment from the patient. Update received from customer on (b)(6) stated the was device used for a carpal scaphoid nonunion screwing. The event happened when preparing the location of the screw head by hand and without force. Rupture of a tooth of the cutter within the scaphoid. The fragment was not possible to retrieve. Delay of 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
[53951301]
The reported event that a countersink, cannulated autofix 2. 0/2. 5 broke during surgery could be confirmed. Based on investigation, the root cause was attributed to a user related issue. The most likely cause is that the integrity of the instrument had not been verified prior to use. The countersink had experienced excessive use or force in previous surgeries, its tip got damaged/worn and thus became susceptible to breakage. The device inspection revealed that the device does not present any signs of rust or discoloration. The tip results broken and shows a helical fracture. Fatigue zones can be observed on the breakage surfaces. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. The instruction for use (v15138 rev b systeme autofix non sterile lbl 0898) was reviewed: examine instruments for wear or damage before use. While rare, intra-operative instrument breakage may occur. Instruments that have experienced excessive use or force may be susceptible to breakage. Intra-operative safety precautions prior to use, verify the integrity of the implants and instruments. No indications of material, manufacturing or design related problems were found during the investigation. If any further information is provided, the investigation report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[53951303]
Operating room manager reported the following event, during a procedure, the device fractured and a metal fragment was left inside the patient's bone. The contact person called and the procedure was still ongoing. The surgeon was trying to extract/ remove the fragment from the patient. Update received from customer on sept 22nd stated the was device used for a carpal scaphoid nonunion screwing. The event happened when preparing the location of the screw head by hand and without force. Rupture of a tooth of the cutter within the scaphoid. The fragment was not possible to retrieve. Delay of 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2015-00411 |
| MDR Report Key | 5157918 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-09-22 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2014-02-25 |
| Date Added to Maude | 2015-10-16 |
| 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 | NURSING ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROSE HAAS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUNTERSINK, CANNULATED AUTOFIX 2.0/2.5 |
| Generic Name | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS |
| Product Code | HWW |
| Date Received | 2015-10-16 |
| Returned To Mfg | 2015-10-09 |
| Catalog Number | 9071003 |
| Lot Number | X0865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-16 |