MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 24MM; 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)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Patient weight not available for reporting.Date of event reported as 2016, exact date of non-union is not known.Additional product code: hrs, jds.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.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 non union 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, eight (8) additional devices are captured in (b)(4).This report addresses devices identified in additional information received on august 1, 2018.This report is for one (1) 3.5mm cortex screw.This is report 6 of 8 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Occupation: reporter is lawyer.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
Due to database limitations, six (6) additional devices are captured in (b)(4) and five (5) additional devices are captured under complaint (b)(4).This is report 6 of 7 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 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: 7799684
• Report Number: 2939274-2018-53392
• Device Sequence Number: 182067
• 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: Physician
• Type of Report: Initial,Followup
• 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: 204.824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR