MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM KIRSCHNER WIRE W/TROCAR POINT 285MM; WIRE, SURGICAL

Catalog Number 292.260S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Additional procode: hty.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, open reduction internal fixation surgery for the right proximal humeral fracture was performed with multiloc humeral nail and k-wire.During the surgery, the surgeon inserted the k-wire and drilled the bone with a crown reamer.During the drilling, the reamer interfered with the k-wire, and the tip of the k-wire broke.The fragment adhered to the reamer and it is not likely that other fragments remained in the patient body.The surgeon confirmed no fragments in the body by postoperative x-ray.The procedure was completed with no surgical delay.This report is for a 2.5 mm kirschner wire with trocar point.This is report 1 of 1 for (b)(4).

• Brand Name: 2.5MM KIRSCHNER WIRE W/TROCAR POINT 285MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8855139
• MDR Text Key: 153405901
• Report Number: 8030965-2019-66791
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819265097
• UDI-Public: (01)07611819265097
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.260S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2019
• 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