MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-08 for SLIDE HAMMER FOR HAMMER GUIDE 357.25 manufactured by Synthes Brandywine.
[15423645]
It was reported that 8 instruments are leaching a brown residue from the handles. There was a delay to a procedure to reclean the instruments. The next time through sterile processing the handles began leaching again. The consultant replaced all parts through a port, as they were needed for upcoming cases. Instruments were reportedly old and needed replacing. This is 4 of 10 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[15603707]
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. Additional product code: fzy. The dhr was reviewed and no issues that would have resulted in this complaint were found. The device was received, however, no evaluation is available.
Patient Sequence No: 1, Text Type: N, H10
[28481691]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Blank fields on this form indicate the information is unknown, unavailable or unchanged. 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. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[28481692]
This is report 4 of 10 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[33954435]
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. The product development event evaluation showed all of the returned parts have phenolic handles which is a standard instrument handle material that has been used for years. The complaint notes that there is brown residue leaching from the handles but the parts were decontaminated when returned from the field and there was no residue on the parts when they were received for evaluation. There have been a limited number of complaints for this condition on instruments with the phenolic (canvesit) material and there have been thousands of instruments distributed with handles made with this material. The following shows the manufacturing dates for the instruments and it is evident that the returned parts were all manufactured several years ago and have been used without issue for quite some time. The 357. 406 (manufactured in july 2003 and september 2004), the 357. 25 (may 2003 and november 2008), the 314. 75 (june 2003 and september 2004), the 357. 515 (may 2003 and january 2005), the 399. 42 (february 2009), and the 399. 43 (june 2005). The parts were decontaminated when returned from the field and any residue that was on the parts was removed prior to being received for evaluation. Since the complaint condition could not be verified or evaluated, this complaint is dispositioned indeterminate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530088-2013-10347 |
| MDR Report Key | 3041785 |
| Report Source | 05,07 |
| Date Received | 2013-04-08 |
| Date of Report | 2012-03-21 |
| Date Mfgr Received | 2012-06-18 |
| Device Manufacturer Date | 2008-11-18 |
| Date Added to Maude | 2013-06-06 |
| 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 BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLIDE HAMMER FOR HAMMER GUIDE |
| Product Code | HXL |
| Date Received | 2013-04-08 |
| Returned To Mfg | 2012-05-03 |
| Catalog Number | 357.25 |
| Lot Number | 6024845 |
| 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 BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-08 |