MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED SCREW 16MM THREAD/55MM; SCREW, FIXATION, BONE

Model Number	208.850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure because of malunion/nonunion and possible infection due to gunshot wound without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn.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 removal of 7.3mm cannulated screw 16mm thread/50mm, 7.3mm cannulated screw 16mm thread/55mm and plate from proximal femur and revised to 130 degree blade plate due to malunion/nonunion and possible infection due to gunshot wound.It is unknown if there was surgical delay.Procedure was successfully completed.Patient status is unknown.This complaint captures the post-op event while (b)(4) captures the intra-op event.This complaint involves three (3) devices.This report is for one (1) 7.3mm cannulated screw 16mm thread/55mm.This report is 2 of 3 for (b)(4).

• Brand Name: 7.3MM CANNULATED SCREW 16MM THREAD/55MM
• 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: 8524762
• Report Number: 2939274-2019-57537
• Device Sequence Number: 1885037
• Product Code: HWC
• UDI-Device Identifier: 10886982149930
• UDI-Public: (01)10886982149930
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K962011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/25/2019

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: 208.850
• Device Catalogue Number: 208.855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR