MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	202.216
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 patient identifier: (b)(6).Additional device product code: hrs; ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(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
It was reported that a patient underwent initial surgery on (b)(6) 2018 to treat an ankle fracture.X-ray taken on an unknown postoperative date revealed malreduction.The initial plate placement put the fibula in valgus.Patient underwent revision surgery on (b)(6) 2018 for a hardware removal.The plate was removed, and a 1/3 tubular was used for final fixation.The procedure was completed successfully.It is unknown if there was a surgical delay.Patient outcome is unknown.This report is for one (1) 2.7mm locking screw self-tapping with t8 stardrive recess 16mm.This is report 10 of 10 for complaint (b)(4).

• Brand Name: 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7996705
• Report Number: 2939274-2018-54542
• Device Sequence Number: 13896631
• Product Code: HWC
• UDI-Device Identifier: 10886982143990
• UDI-Public: (01)10886982143990
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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): 09/28/2018

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: 202.216
• Device Catalogue Number: 202.216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 96