MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/20MM; SCREW, FIXATION, BONE

Model Number	04.118.520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Date of event is unknown.Lot number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter facility, street address, and email address are unknown.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 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.(b)(4).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 during ankle reconstruction on an unknown date, the head of a 2.7mm titanium (ti) metaphyseal screw broke off when it was powered down to an unknown titanium locking compression plate (lcp) distal tibia plate with an unknown drill.The plate was removed temporarily to retrieve the broken screw, then the plate was placed back to fix the fracture.There was an unknown surgical delay reported.Patient outcome is unknown.Concomitant device: titanium lcp distal tibia plate (part: unknown, lot: unknown, quantity: 1), drill (part: unknown, lot: unknown, quantity: 1).This report is for a 2.7mm ti metaphyseal screw self-tapping with t8 stardrive recess/20mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/20MM
• 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: 7728357
• Report Number: 2939274-2018-53106
• Device Sequence Number: 996405
• Product Code: HWC
• UDI-Device Identifier: 10886982108845
• UDI-Public: (01)10886982108845
• Combination Product (Y/N): N
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.118.520
• Device Catalogue Number: 04.118.520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR