MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 28MM; SCREW, FIXATION, BONE

Model Number	204.824
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient¿s weight is not provided for reporting.Additional device product codes: hrs, jds.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is lawyer.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 on or around (b)(6) 2016 surgeon performed a correction of nonunion of left supracondylar humerus fracture.Depuy synthes hardware was explanted and bone graft was implanted.Surgeon also performed neurolysis of the left ulnar nerve.Due to database limitations, six (6) additional devices are captured in (b)(4) and seven (7) additional device are captured under (b)(4).This report addresses devices identified in additional information received on august 1, 2018.This report is for one (1) 3.5 mm cortex screw self-tapping 28 mm.This is report 3 of 5 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 28MM
• 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: 7802794
• Report Number: 2939274-2018-53421
• Device Sequence Number: 228883
• Product Code: HWC
• UDI-Device Identifier: 10886982146304
• UDI-Public: (01)10886982146304
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.824
• Device Catalogue Number: 204.828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention