MAUDE Adverse Event Report: SYNTHES GRENCHEN 4.5MM TI MULTILOC SCREW LENGTH 38MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.019.038

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

Patient Problems Sedation (2368); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age, dob gender & weight not available for reporting.Udi: (b)(4) lot number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted device is not expected to be returned for manufacturer review/investigation.The reported event required medical/surgical intervention to preclude permanent damage to a body structure.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

Device report from synthes on an event in (b)(6) as follows: it was reported that during a humeral fracture fixation, using a multiloc nail, after they insert the a multiloc screw, they needed to adjust its position, while doing so, they pushed the screw and it went through from the other side of the nail, they managed to take it out after an hour delay.No reported adverse event to patient.This complaint involves one parts.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Brand name correction.Device 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.

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 38MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6822234
• MDR Text Key: 83701028
• Report Number: 3009450884-2017-10110
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• 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,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• 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