MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) PLATE 8 HOLES/76MM; PLATE,FIXATION,BONE

Model Number 247.372

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

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Unknown date in 2018.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history: lot part: 247.372; lot: l770621; manufacturing site: (b)(4); release to warehouse date: 13.Feb.2018.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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 (b)(6) 2018, the patient underwent a hardware removal of a locking compression plate (lcp) plate, six (6) unknown cortex screws, and an unknown locking screw on a distal ulna fracture.This was due to non-union and the plate positioned incorrectly in the distal radial ulnar joint.The plate was removed, the edges of the fracture were corrected, and a new lcp plate was implanted.All hardware was removed successfully.The original surgery was an open fracture on (b)(6) 2018.It is unknown if there was a surgical delay.There was no patient consequence.This report is for one (1) 2.7mm lcp(tm) plate 8 holes/76mm.This is report 1 of 3 for (b)(4).

• Brand Name: 2.7MM LCP(TM) PLATE 8 HOLES/76MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8181532
• MDR Text Key: 130924256
• Report Number: 2939274-2018-55485
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982170873
• UDI-Public: (01)10886982170873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 247.372
• Device Catalogue Number: 247.372
• Device Lot Number: L770621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 68