MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unknown k wire.Part and lot numbers are unknown; udi number is unknown.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for clavicle shaft fracture with the k-wire in question.The surgeon fixed the plate with the k-wire, the lcp drill sleeve and the k-wire sleeve.The reduction was acquired by drawing the bone to the plate with a pliers.The surgeon inserted a cortex screw through the plate.Because the surgeon considered the possibility that the k-wire bowed, the surgeon tried to remove the k-wire.When the surgeon removed the k-wire sleeve and he tried to remove the k-wire through the drill sleeve, the k-wire broke.The surgeon was able to remove the fragment with a longnose pliers in the hospital.The surgery was delayed about 10 minutes, but the surgery was completed successfully.Concomitant devices reported: lcp superior anterior clavicle plate (part# 04.112.021, lot# unknown, quantity# 1), lcp drill sleeve part# 323.027, lot# unknown, quantity# 1), unknown k-wire sleeve (part# unknown, lot# unknown, quantity# 1), unknown cortex screw (part# unknown, lot# unknown, quantity# unknown), unknown pliers (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9412485
• MDR Text Key: 195102836
• Report Number: 8030965-2019-70737
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1