MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 52MM; APPLIANCE,FIXATION,NAIL

Model Number	212.122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: 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) 2019, the patient underwent open reduction internal fixation (orif) of proximal humerus.The one (1) locking compression plate proximal humerus plate-standard 3h head shaft, one (1) cortex screw self-tapping 34mm, one (1) cortex screw self-tapping 30mm, two (2) locking screw self-taping with stardrive recess 52mm, one (1) locking screw self-taping with stardrive (tm) recess 40mm, one (1) locking screw self-taping with stardrive recess 48mm, one (1) locking screw self-taping with stardrive (tm) recess 38mm, one (1) locking screw self-taping with stardrive (tm) recess 50mm, one (1) locking screw self-taping with stardrive recess 46mm and one (1) locking screw self-taping with stardrive (tm) recess 32mm was removed due to nonunion of the right proximal humerus fracture of the patient.Hardware was implanted on (b)(6) 2017.All hardware was removed successfully and intact.Nothing was broken.It is unknown if there was surgical delay.Procedure was successfully completed.Patient status is unknown.This complaint reports total 11 devices.Due to system limitation ten (10) devices are captured under related complaint (b)(4) and remaining one (1) device is captured under this complaint (b)(4).This report is for one (1) 3.5mm locking screw 52mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 52MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8492893
• Report Number: 2939274-2019-57365
• Device Sequence Number: 19226431
• Product Code: KTT
• UDI-Device Identifier: 10886982151964
• UDI-Public: (01)10886982151964
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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: 212.122
• Device Catalogue Number: 212.122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention