MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-17 for SYNFIX? EVOLUTION AWL/WITHOUT SLEEVE 03.835.032 manufactured by Synthes Hagendorf.
[60287477]
Device used for treatment, not diagnosis. Patient information not available for reporting. Implant and explant dates: device is an instrument and is not implanted/explanted. Date returned to manufacturer. Pma 510(k): no 510(k) because this is a class 1 exempt instrument. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: part # 03. 835. 032, lot # 9932633, manufacturing location: (b)(4), manufacturing date: 24. Jun. 2016. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[60287478]
It was reported that the patient underwent an anterior lumbar interbody fusion (alif) procedure from l5-s1 on (b)(6) 2016. During the case the synfix? Evolution awl/without sleeve was binding up (. I. E. Stopping) on the aiming device. The instrument was sweeped into proper position and the surgeon was able to successfully complete the procedure. This event resulted in a 10 minute surgical delay. No patient harm was reported. Patient reported as stable. Procedure completed successfully. There is no malfuction associated with this aiming device. This complaint involves one device.. Concomitant devices reported: aiming device (part # unknown, lot # unknown, quantity # 1). This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[63836273]
The manufacturer investigation results are as follows. The returned awl was examined and the tip was found to be deformed. Additionally surface wear (worn finish, scratching, etc. ) was noted on the distal tip towards the universal joint. The complaint condition of binding with the aiming device was unable to be replicated as an aiming device was not returned. As such the complaint is unconfirmed. Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level (se_547480 revision k) and awl tip (se_547481 revision e). The design, materials and finishing processes were found to be appropriate for the intended use of this device. A device history review was performed for the returned instrument? S lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. 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
| Report Number | 3003875359-2016-10602 |
| MDR Report Key | 6110897 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-17 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-12-20 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2016-11-17 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNFIX? EVOLUTION AWL/WITHOUT SLEEVE |
| Generic Name | AWL (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT) |
| Product Code | HWJ |
| Date Received | 2016-11-17 |
| Returned To Mfg | 2016-11-14 |
| Catalog Number | 03.835.032 |
| Lot Number | 9932633 |
| ID Number | (01)10705034814179(10)9932633 |
| 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 HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-17 |