MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-08 for APPLICATION INSTR W/ALIGNMENT GUIDE FOR CRANIAL TUBE CLAMP 329.323 manufactured by Umkirch.
[48250895]
Patient information is not available for reporting. Device is an instrument and is not implanted or explanted. The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). Investigation could not be completed and no conclusion could be drawn as no device was returned. Device history record review: manufacturing site: (b)(4)- manufacturing date: january 27, 2009. No non-conformance reports were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device 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
[48250896]
Device report from synthes (b)(4) reports an event as follows: it was reported that a patient underwent a cranioplasty on (b)(6) 2016. During the procedure, the application instrument for the cranial tube clamp did not seat the clamps as expected. An additional instrument tray was available and opened. The same instrument from the new set was used to successfully complete the procedure. A minor delay of an unspecified amount of time was noted. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[48565437]
Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Device 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
[50639353]
Product investigation summary: the application instrument (part: 329. 323 / lot: 3076204) was returned with a report that it would not be seat the clamps as it should. The complaint condition was likely caused by dullness and wear from over seven years of consistent use; however, this complaint is not likely a result of any design or manufacturing related deficiency. A visual inspection, functional test and drawing review were performed as part of this investigation. The application instrument is routinely used in the cranial clamps with application instrument system. The crimping and cutting edges of the returned device show some wear and dullness that could possibly preclude proper clamp fixation. The device was manufactured in january, 2009 and is over seven years old. The balance of the returned device is in otherwise good condition, although the spring mechanism does run somewhat roughly. The relevant drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used as recommended. The condition of the returned device does agree with the complaint description. Whether the complaint condition for this device can be replicated is not applicable. Upon review of the device history record, no non-conformances were noted during the production of this device. Device 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
| Report Number | 3003862213-2016-10018 |
| MDR Report Key | 5706039 |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-30 |
| Date Mfgr Received | 2016-07-26 |
| Device Manufacturer Date | 2009-01-27 |
| Date Added to Maude | 2016-06-08 |
| 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 | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | UMKIRCH |
| Manufacturer Street | IM KIRCHENHURSTLE 4 |
| Manufacturer City | UMKIRCH B. FREIBURG D-79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLICATION INSTR W/ALIGNMENT GUIDE FOR CRANIAL TUBE CLAMP |
| Generic Name | CRIMPER, PIN |
| Product Code | HXQ |
| Date Received | 2016-06-08 |
| Returned To Mfg | 2016-06-15 |
| Catalog Number | 329.323 |
| Lot Number | 3076204 |
| ID Number | (01)10887587039299(10)3076204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UMKIRCH |
| Manufacturer Address | IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG D-79224 GM D-79224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-08 |