MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 38MM; NAIL,FIXATION,BONE

Model Number	212.116
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 id: (b)(6).Date of event is unknown.Additional device code: ktt.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 report that the patient had original surgery on (b)(6) 2016 for treatment of a tibial fracture.Patient was implanted with one (1) 3.5mm locking compression reconstruction plate 10 holes/140mm, three (3) 3.5mm locking screws with recess 38mm and one (1)3.5mm locking screw with recess 44mm.On an unknown date post-operative, patient was presented with exposure of hardware at the tibia bone.The soft tissue had eroded around the construct implant site.On (b)(6) 2017, surgeon removed all implants.The tibial bone fractured has healed, so no new bone fixation was needed.No infection was reported and it was observed that the implants were in good condition when removed.No fragments were generated during implant removal.Revision surgery was completed successfully with no time delay.Patient was reported in stable condition.This report is for one (1) 3.5mm locking screw slf-tpng w/stardrive¿ recess 38mm.This is report 4 of 5 for (b)(4).
Additional Manufacturer Narrative
Product was not returned and no lot number was provided.Based on the information available, 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.

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 38MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• MDR Report Key: 7104947
• Report Number: 2939274-2017-50204
• Device Sequence Number: 1378921
• Product Code: JDS
• UDI-Device Identifier: 10886982151902
• UDI-Public: (01)10886982151902(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017

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: 212.116
• Device Catalogue Number: 212.116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 54