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 2017-01-17 for AWL F/TEN 359.213 manufactured by Synthes Hagendorf.
[65032801]
Device used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Device history records review was conducted. The report indicates that the: manufacturing location: (b)(4); manufacturing date: 06. Oct. 2005. 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
[65032802]
Device report from synthes on an event in (b)(6) as follows: it was reported that is was an open fracture reduction in humeral shaft with internal fixation. When the specialist performed the piercing with the punch, the tip broke. No prolongation of the surgery was reported. Patient status is normal. The puncture tip, that was split, was inside the channel of the patient's bone; however, the specialist stated that it does not represent any risk to the patient. The procedure was completed successfully. No other medical intervention was required. This complaint involves 1 part. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[69009424]
Additional narrative: device returned to manufacturer. (b)(6). A product investigation was performed. The investigation shows that the tip of the awl is broken as described in the complaint description. The broken tip part was not returned. There are different nicks and striations signs on the entire device visible. The review of the production histories revealed that this awl was manufactured in october 2005 according to the specifications. No manufacturing related issues that would have contributed to this complaint were found. Because of the damage, the complaint relevant dimensions cannot be checked anymore. Since this instrument is quit old it is considered as normal wear and tear after frequent use. Although the exact cause cannot be determined, this complaint condition is likely a result of wear and tear. No product related issues were found. 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
[69459230]
Initial (b)(4) submitted as product malfunction only has been corrected to product malfunction and serious injury. 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
[69459427]
(b)(4). 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 | 3003875359-2017-10024 |
| MDR Report Key | 6258797 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-17 |
| Date of Report | 2016-12-26 |
| Date of Event | 2016-12-26 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2005-10-06 |
| Date Added to Maude | 2017-01-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AWL F/TEN |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2017-01-17 |
| Returned To Mfg | 2017-01-31 |
| Catalog Number | 359.213 |
| Lot Number | 1399899 |
| 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 | 1. Required No Informationntervention | 2017-01-17 |