MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM; APPLIANCE,FIXATION,NAIL

Model Number	280.305
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
Additional product code: jdo.Implanted in (b)(6) 2018; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid.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 the patient underwent a hardware removal of dynamic hip screw (dhs) implant constructs for a femoral neck fracture on (b)(6) 2019 as that ended up not healing.Surgeon took out the hardware and revised patient to total hip arthroplasty.Dhs was removed with no issues.Original implant date was (b)(6) 2018.It is unknown if there was surgical delay.Procedure was successfully completed.Patient outcome was unknown.This report is for one (1) dhs/dcs one step lag screw.This is report 2 of 3 for complaint (b)(4).

• Brand Name: DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/105MM
• 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: 8649504
• Report Number: 2939274-2019-58356
• Device Sequence Number: 3236874
• Product Code: KTT
• UDI-Device Identifier: 10886982175236
• UDI-Public: (01)10886982175236
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K964259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/29/2019

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: 280.305
• Device Catalogue Number: 280.305
• Device Lot Number: 863934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 64