MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.127.231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The device history record: part: 02.127.231, lot: l735177, manufacturing site: (b)(4), release to warehouse date: 16.January 2018.The device history record shows this lot of 6 pieces 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 a 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned.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 was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, the patient underwent hardware removal due to the bone being healed and to avoid infection.Screws removed were five (5) unknown 3.5 variable angle (va) locking screws, six (6) unknown 3.5 cortex screws, four (4) unknown 2.4 cortex screws, 1 (one) 3.5 va-locking compression plate (lcp) proximal tibia plate and one (1) 2.4 lcp plate 4 holes.All hardware successfully removed with no issues.Original implant was on april 30,2018.There were no known comorbidities.There was no patient consequence reported.It is unknown if there was surgical delay.Procedure and patient outcome is unknown.This complaint involves (5) reports totaling seventeen (17) devices.This complaint is for (1) 3.5mm va-lcp prox tibia plate small bend.This report is 1 of 5 for (b)(4).

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7957936
• Report Number: 2939274-2018-54330
• Device Sequence Number: 1514675
• Product Code: HRS
• UDI-Device Identifier: 10886982043566
• UDI-Public: (01)10886982043566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.127.231
• Device Catalogue Number: 02.127.231
• Device Lot Number: L735177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Weight: 56