MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 24MM; SCREW, FIXATION, BONE

Model Number	412.824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s identifier, date of birth/age and weight are unknown.Date of postoperative screw breakage is unknown.Additional device product code: hrs.Date of original implant is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).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 that a revision surgery took place on (b)(6) 2018 after the patient presented pain in the wrist following an unknown procedure.X-rays were taken and revealed broken screws and loss of reduction.The surgeon removed the four broken screws, an unknown quantity of locking screws (not broken) and the 2.4 va-lcp two column plate and replaced them with a competitor¿s product (hand innovations).No fragments were generated from the broken screws.The revision surgery was completed successfully with no delays and no harm to the patient.Concomitant devices reported: 2.4mm ti va-lcp 2-clmn vlr (part 04.111.631, lot unknown, qty 1), unknown locking screws (part unknown, lot unknown, qty unknown).This is report 2 of 4 for complaint (b)(4).

• Brand Name: 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 24MM
• 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: 7455829
• Report Number: 2939274-2018-51899
• Device Sequence Number: 1372978
• Product Code: HWC
• UDI-Device Identifier: 10886982211668
• UDI-Public: (01)10886982211668
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• 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): 04/04/2018

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: 412.824
• Device Catalogue Number: 412.824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/24/2018
• 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