MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM; SCREW, FIXATION, BONE

Model Number	02.211.032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height reported as 5¿4¿.Additional product code: hrs.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.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) 2018, the patient underwent a hardware removal due to pain.During the procedure, five (5) variable angle (va) locking screws were broken.The broken screws were fully removed.The bone was healed.No additional hardware was placed.The procedure was completed successfully with no surgical delay.Revision surgery due to pain is addressed in (b)(4).This report addresses the intraoperative issue with broken screws.Concomitant devices: 3.5mm cortex screw 22mm (part 204.822, lot unknown, quantity 1), 3.5mm cortex screw 24mm (part 204.824, lot unknown, quantity 2), 3.5mm cortex screw 30mm (part 204.830, lot unknown, quantity 1), 3.5mm cortex screw 16mm (part 204.816, lot unknown, quantity 1), 3.5mm cortex screw 12mm (part 204.812, lot unknown, quantity 2), 3.5mm locking screw 10mm (part 212.101, lot unknown, quantity 1), 3.5mm locking screw 14mm (part 212.103, lot unknown, quantity 1), lcp one-third tubular plate with collar 69mm (part 241.361, lot h398866, quantity 1), 2.7/3.5mm va-lcp medial distal tibia plate-right (part 02.118.004, lot 9512579, quantity 1).This report is for one (1) 2.7mm va locking screw.This is report 3 of 5 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 32MM
• 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: 7977469
• Report Number: 2939274-2018-54465
• Device Sequence Number: 1263105
• Product Code: HWC
• UDI-Device Identifier: 10886982053671
• UDI-Public: (01)10886982053671
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: 02.211.032
• Device Catalogue Number: 02.211.032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/18/2018
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 72