MAUDE Adverse Event Report: SYNTHES USA; PASSER, WIRE, ORTHOPEDIC

Catalog Number 292.160

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown k-wire ø1.6 l150 /unknown lot number.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that the surgeon felt a touch when he was drilling on the bone for do the hole for the screw.He placed the screw, and checked the position with x- rays, then he saw that the kirschner wire was broken in the tip and the tip of the wire was left into the patient's bone, the rest part of the wire was discarded in the hospital.The surgeon decides to leave the tip of the wire into the patient's bone.No prolongation in surgery reported, and no patient harm reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the given information on the device report has indicated that the implant has migrated from the vertebral body.Without having the material we cannot give a conclusive statement regarding the possible failure reason.No further information as well as the lot numbers had been made available, therefore, an investigation could not be performed.Since the lot number is not known, we could not verify the production documents.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.

• Type of Device: PASSER, WIRE, ORTHOPEDIC
• Manufacturer (Section D): SYNTHES USA; 1302 wright lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5069657
• MDR Text Key: 25483134
• Report Number: 2520274-2015-15782
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR