MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 7H/RT/127MM-LONG; PLATE, FIXATION, BONE

Model Number 02.117.207

Device Problems Fitting Problem (2183); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hwc.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on an unknown date, the variable angle (va) self tapping locking screw went through the va locking compression plate (lcp) posterolateral distal humerus plate.The surgeon was using the va elbow system.The case was going fine until the last screw placement into the plate.The surgeon predrilled with a drill bit on a nominal angle.The surgeon powered the locking screw down, and stopped short of the plate and went to tighten by hand and the screw went directly through plate countersinking into the bone.The screw was not into the joint so the surgeon decided to leave the screw implanted in the bone.No action was done due to it would require taking all of the screws and the plate off and starting over.If the screw migrates into the joint, the patient would have to come back for a revision.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.Concomitant device reported: drill / drill bit (part# 323.062 lot# unknown, quantity# 1).This complaint involves one (1) device, 2.7mm/3.5mm va-lcp postlat dstl hum pl 7h/rt/127mm-long.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 7H/RT/127MM-LONG
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7920627
• MDR Text Key: 122479155
• Report Number: 2939274-2018-53995
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982036162
• UDI-Public: (01)10886982036162
• Combination Product (y/n): N
• PMA/PMN Number: K120717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.117.207
• Device Catalogue Number: 02.117.207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Patient Sequence Number: 1
• Patient Age: 79 YR