MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM; NAIL,FIXATION,BONE

Model Number	212.103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of infection is not known.Additional product codes: ktt.Date of implant is not known.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.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 patient underwent an open reduction internal fixation (orif) of the left midshaft radius fracture on an unknown date.A 3.5mm 10 hole locking compression plate (lcp) and nine (9) screw were implanted at that time.On an unknown date, patient developed an abscess infection on the left forearm.Patient was returned to surgery on (b)(6) 2018 where all hardware was successfully removed.During the removal procedure, one (1) cortex screw was noted to be broken, also removed successfully.(b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7332900
• Report Number: 2939274-2018-51026
• Device Sequence Number: 13854297
• Product Code: JDS
• UDI-Device Identifier: 10886982151773
• UDI-Public: (01)10886982151773(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: 212.103
• Device Catalogue Number: 212.103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/12/2018
• 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: 49 YR