MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI LOCKING SCREW W/T25 STARDRIVE 76MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.666
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
It was reported that on (b)(6) 2018 a patient underwent hardware removal due to infection.The devices removed were one (1) hindfoot arthrodesis cannulated nail, one (1) titanium spiral blade, one (1) 6.0mm titanium locking screw, one (1) titanium end cap, one (1) titanium locking screw 50mm, and two (2) titanium locking screws 30mm.The original implant for the devices is (b)(6) 2018.The patient and procedure outcome is unknown.Concomitant devices reported: vivigen formable biologic tissue matrix (product# bl-1600.002, lot unknown, quantity 1).This report is for (1) 6.0mm ti locking screw w/t25 stardrive 76mm for im nails this complaint involves seven (7) devices.This report is 3 of 7 for (b)(4).

• Brand Name: 6.0MM TI LOCKING SCREW W/T25 STARDRIVE 76MM FOR IM NAILS
• 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: 8002114
• Report Number: 2939274-2018-54580
• Device Sequence Number: 16215516
• Product Code: HWC
• UDI-Device Identifier: 10886982086907
• UDI-Public: (01)10886982086907
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K970733
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 04.005.666
• Device Catalogue Number: 04.005.666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention