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 2017-03-21 for K-WIRE ?1.8 L280 SST 10U 292.190.10 manufactured by Synthes (usa).
[70411909]
Device was used for treatment, not diagnosis. Patient weight is not available for reporting. (b)(4). Device is an instrument and is not implanted/explanted. The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received. Reporting facility phone numbers are (b)(6). 510(k): device is not distributed in the united states, but is similar to device marketed in the usa. The investigation could not be completed; no conclusion could be drawn, as no product was received. Without a lot number the device history records review could not be completed. The date of manufacture and expiration date are unknown. 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
[70411910]
Device report synthes europe reported an event in (b)(6) as follows: it was reported that during an unspecified surgery on (b)(6) 2017 the head of the k-wire broke off and the fragment was retained in the patient. It was further reported that the k-wire was inserted through the guide without any force or pressure. The reported issue was discovered when x-rays were taken. There was no surgical delay. Reported concomitant devices: guide (part / lot: unknown, quantity: 1). This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[74533653]
The review of the received x-ray, it can be confirmed that the device was embedded. (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
[74533654]
Reported concomitant devices: positioner for aiming block (part: 03. 108. 006, lot: unknown, quantity: 1)
Patient Sequence No: 1, Text Type: D, B5
[74925886]
Device was used for treatment, not diagnosis. The reported information from the device report has indicated that the wire was un-headed and remained within the patient? S bone. Without having the subject device, synthes cannot provide a conclusive statement regarding the possible failure reason. No further information, as well as the lot number, had been made available therefore an investigation could not be performed. Since the lot number is not known, synthes could not verify the production documents. The review of the x-rays reviewed by synthes confirmed the complaint condition regarding the embedded device (as previously reported). A root cause cannot be determined. 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 | 2520274-2017-10948 |
| MDR Report Key | 6419827 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-21 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-03-21 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-WIRE ?1.8 L280 SST 10U |
| Generic Name | PASSER,WIRE,ORTHOPAEDIC |
| Product Code | HXI |
| Date Received | 2017-03-21 |
| Catalog Number | 292.190.10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-21 |