MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 100MM; SCREW, FIXATION, BONE

Model Number	214.900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of event: date of postoperative screw breakage is unknown.Additional device product code: ktt initial implant date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.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 was performed on (b)(6) 2018.The patient was initially implanted with four (4) 4.5 mm self-tapping cortex screws on an unknown date.Two (2) screws out of the four (4) screws broke postoperatively due to a nonunion of pelvis osteotomy.The surgeon removed all the four screws and put in new screws and plates.There is no information provided regarding the status of the patient and the procedure.Concomitant device (s) reported: 4.5mm cortex screw self-tapping 100mm (part # 214.900, lot # unknown, qty 2).This is report 2 of 2 for complaint (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 100MM
• 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: 7339135
• Report Number: 2939274-2018-51057
• Device Sequence Number: 187801
• Product Code: HWC
• UDI-Device Identifier: 10886982154910
• UDI-Public: (01)10886982154910(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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): 02/14/2018

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: 214.900
• Device Catalogue Number: 214.900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/14/2018
• 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