MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 MM VA-LCP LAT DIS FIB 5H L; PLATE, FIXATION, BONE

Model Number	02.118.405
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hwc.Plate remained implanted; as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes employee.(b)(4).Without a lot number the device history records review could not be completed.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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent an open reduction internal fixation of ankle on (b)(6) 2018.While using the variable angle locking compression plate (va-lcp) lateral distal fibula plate, the surgeon was unable to successfully lock the three most distal, posterior holes in the plate.The appropriate drill bit, drill guide and screwdriver and technique was used.This caused unspecified surgical delay while trying to lock the screws, remove the screws, re-insert and try different screws (2.7mm metaphyseal).The distal anterior screws locked, and the surgeon did not want to remove the plate as fracture reduction was achieved and more harm could possibly follow for removing it and trying a different plate.Patient and surgical outcome was unknown.Concomitant device reported: drill bit (part/lot number unknown, quantity 1), drill guide (part/lot number unknown, quantity 1), screwdriver (part/lot number unknown, quantity 1), distal anterior screws (part/lot number unknown, quantity unknown).This report is for one (1) 2.7mm va-lcp lateral distal fibula plate.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 2.7 MM VA-LCP LAT DIS FIB 5H L
• 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: 7974416
• Report Number: 2939274-2018-54424
• Device Sequence Number: 16447692
• Product Code: HRS
• UDI-Device Identifier: 10886982038883
• UDI-Public: (01)10886982038883
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: 02.118.405
• Device Catalogue Number: 02.118.405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention