MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH K-WIRE 3 L280 SST 10U; WIRE,SURGICAL

Catalog Number 292.310.10

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the surgeon opened new k-wire and products appeared to have been used.There was no patient consequence.No further information is available.This report is for one (1) k-wire ø3 l280 sst 10u.This is report 1 of 1 for (b)(4).

• Brand Name: K-WIRE 3 L280 SST 10U
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10491942
• MDR Text Key: 208805430
• Report Number: 8030965-2020-06618
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819321540
• UDI-Public: (01)07611819321540
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.310.10
• Device Lot Number: 3L59904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1