MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE,SURGICAL

Catalog Number 292.160.01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2019; however exact date of postoperative plate breakage, non-union and infection development is unknown.Additional device product code: hty.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 the patient underwent an open reduction internal fixation (orif) revision procedure of distal humerus on (b)(6) 2019 due to broken plate, and non-union.Non-union was developed potentially due to infection.Hardware was removed and new construct was implanted.Initial implant date is reported as (b)(6) 2019.This complaint involves total twenty (20) devices.This complaint (b)(4) captures 10 devices and related complaint (b)(4) captures remaining 10 devices.This report is for one (1) 1.6 mm k-wire w/ trocar point 150 mm.This is report 10 of 10 for complaint (b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9476458
• MDR Text Key: 171596989
• Report Number: 8030965-2019-71150
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319707
• UDI-Public: (01)07611819319707
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PREAMENDMENT
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.160.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention