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

Catalog Number 292.160S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative 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 on (b)(6) 2020, during an unknown procedure, the k-wire broke inside the patient¿s bone during drilling.The broken thread was left inside the patient's bone.No further information provided.Concomitant devices reported: 3.2mm cannulated drill bit/qc 170mm (part# 310.65, lot# unknown, quantity# 1).This report is for one (1) 1.6mm kirschner wire w/trocar point 150mm.This is report 1 of 2 for (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: 10467612
• MDR Text Key: 206804864
• Report Number: 8030965-2020-06453
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819265011
• UDI-Public: (01)07611819265011
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.160S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• 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