MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 3H/LEFT/73MM; PLATE, FIXATION, BONE

Model Number	02.112.137
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Additional procode: hwc.Lot number is unknown.Device has not been explanted.Complainant part 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.(b)(4).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 or Problem Description
It was reported that on (b)(6) 2018, the sales consultant was checking a 3.5 lcp distal fibula tray to prepare for a case.He found that a left ankle plate and two (2) screws were missing.The hospital contact reported to him that on (b)(6) 2018, a patient was implanted with the missing left ankle plate on the right ankle.An x-ray was shown to the sales consultant to confirm that it was the device that was missing.Sales consultant has no copy of the x-ray.The procedure was completed.Patient's status is unknown.Concomitant devices: 2.7 mm locking screw self-tapping with t8 stardrive recess 10 mm (part: 202.210, lot: unknown, quantity: 2).This report is for a 2.7 mm/3.5 mm locking compression plate (lcp) lateral distal fibula plate 3-hole/left/73 mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 3H/LEFT/73MM
• 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: 7797500
• Report Number: 2939274-2018-53378
• Device Sequence Number: 13500721
• Product Code: HRS
• UDI-Device Identifier: 10886982033871
• UDI-Public: (01)10886982033871
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.112.137
• Device Catalogue Number: 02.112.137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/20/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention