MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 MM VA-LCP LAT DIS FIB 4H R; PLATE,FIXATION,BONE

Model Number	02.118.402
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) of ankle.During the procedure, the surgeon attempted, while using proper technique, to use variable angle locking screws in the distal portion of the variable angle locking compression lateral distal fibula plate, and they would not lock into place.Two (2) different screws were used at different angles, but still unsuccessful.There was a surgical delay of an unknown amount of minutes.The procedure was successfully completed using a non-locking screw.The patient status is unknown.This report is for one (1) 2.7 mm va-lcp lateral distal fibula plate/4 holes/right.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7 MM VA-LCP LAT DIS FIB 4H R
• 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: 8632272
• Report Number: 2939274-2019-58202
• Device Sequence Number: 1857693
• Product Code: HRS
• UDI-Device Identifier: 10886982038821
• UDI-Public: (01)10886982038821
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.118.402
• Device Catalogue Number: 02.118.402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1