MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/95MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	280.295
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: jdo.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 on (b)(6) 2021, an unknown procedure was performed, ria 2 was used with reamer head and the tubing scrunched up due to excessive force.The reamer head broke.On the ipsilateral side a dynamic hip system (dhs) was inserted but the lag screw was ripped during insertion.On the contralateral side two distal fibula plates ended up cross threading the variable angle (va) locking holes.There was a surgical delay of 10 minutes.Concomitant devices reported: ria 2 bone harvesting kit 520mm sterile (part number 03.404.000s, lot unknown, quantity 1).10.0mm reamer head for ria 2 sterile (part number 03.404.016s, lot unknown, quantity 1).2.0mm thrdd guide f/ 2.7mm scr va and lcp (part number 03.133.008, lot unknown, quantity 1).2.7mm va-lcp lateral distal fibula plate/7 holes/right (part number 02.118.408, lot unknown, quantity 1).2.7mm va-lcp lateral distal fibula plate/5 holes/left (part number 02.118.405, lot unknown, quantity 1).This report involves 1 dhs/dcs one-step lag screw 12.7mm thread/95mm.This is report 2 of 4 for (b)(4).

• Brand Name: DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/95MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11272389
• Report Number: 2939274-2021-00643
• Device Sequence Number: 3494141
• Product Code: KTT
• UDI-Device Identifier: 10886982175175
• UDI-Public: (01)10886982175175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K964259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 280.295
• Device Catalogue Number: 280.295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.0MM REAMER HEAD FOR RIA 2; 2.0MM THRDD GUIDE F/ 2.7MM SCR; 2.7MM VA-LCP LAT DIST FIBULA PL RIGHT; 2.7MM VA-LCP LAT DIST FIBULA PLATE LEFT; RIA 2 BONE HARVESTING KIT 520MM