MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP RECONSTRUCTION PLATE7 HOLES/98MM; APPLIANCE,FIXATION,NAIL

Catalog Number 245.071

Device Problem Bent (1059)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was attempted, however, invalid lot number (304731) for part 245.071.Lot number missing one number.Dhr requested.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 not returned and no lot number was provided.Based on the information available, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent revision of a left clavicle plate on (b)(6) 2017 due to bending of the plate.The plate and three (3) 3.5 cortex screws, three (3) 3.5 locking screws, and one (1) unknown cortex screw were originally implanted on (b)(6) 2017.The sales consultant reported that the patient had an overactive trapezius which was bending the plate.The bent plate and all intact screws were removed from the patient.The fracture was reported to be healed, yet the surgeon wanted to revise the patient to another plate construct for an unknown reason.The patient was being revised to one (1) cc of vivigen, one (1) 10 hole 2.7 mm plate, nine (1) 2.7 mm cortex screws and one (1) 2.7 mm locking screws.The procedure conducted was successful with no surgical delay and the patient is stable.X-rays taken during and before the revision procedure won't be available.This complaint involves one (1) device.Concomitant devices reported: 3.5 mm cortex screws (part number unknown, lot number unknown, quantity 3), 3.5 mm locking screws (part number unknown, lot number unknown, quantity 3), unknown cortex screw (part number unknown, lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE7 HOLES/98MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7037124
• MDR Text Key: 92196134
• Report Number: 3006126083-2017-10055
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

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: 245.071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/16/2017
• 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
• Treatment: THE 3.5 MM CORTEX SCREWS, PART/LOT UNK, QTY 3; THE 3.5 MM LOCKING SCREWS PART/LOT UNK, QTY 3; UNKNOWN CORTEX SCREW PART/LOT UNK, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 63