MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-10 for COMPRESSION/DISTRACTIONINSTRUMENT 03.111.021 manufactured by Oberdorf Synthes Produktions Gmbh.
[147512813]
Initial reporter is synthes sales representative. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[147512814]
It was reported that on (b)(6) 2019 the compression/distraction device for foot and ankle hinge was difficult to clean as you cannot see or get a brush in the joint of the device and can not put it apart to clean thoroughly. The sterile services department of the facility has wanted to purchase a foot distractor for capex. And as part of that process, the device was investigated for ease of cleaning and sterilization. The facility investigated this with a small fiber-optic camera and noticed the staining and debris. So, the facility is now going to do a process to see if this is able to be cleaned and if they felt that it cannot be cleaned then the facility is responsible to let all the user know since there was no specific cleaning instruction for this item. In fact, there was a dismantling instruction, tech guide and the generic reprocessing instructions all of which the customer has but these resources do not address the customer concerns. Also, if the facility discovered a way to clean this space, then, they are also happy to share this. The item that was tested was part of the loan set. Hence, the issue that was seen was with the design of the hinge and would apply to all tools of this design. There is no patient involvement. This report is for one (1) compression/distractioninstrument. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-65129 |
| MDR Report Key | 8684313 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-10 |
| Date of Report | 2019-05-14 |
| Date Mfgr Received | 2019-08-05 |
| Date Added to Maude | 2019-06-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSION/DISTRACTIONINSTRUMENT |
| Generic Name | INSTRUMENT COMPRESSION |
| Product Code | HWN |
| Date Received | 2019-06-10 |
| Catalog Number | 03.111.021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-10 |