MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/80MM; APPLIANCE, FIXATION, BONE

Model Number	280.280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: jdo.Device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent hardware removal of a dynamic hip screw (dhs) plate implant due to another traumatic event.The hardware was implanted on an unknown date.It is unknown if there was a surgical delay.Patient and procedure outcome is unknown.This complaint is for (2) devices.This complaint is for (1) dhs®/dcs® one-step lag screw 12.7mm thread/80mme.This report is 2 of 2 for (b)(4).
Event or Problem Description
The dhs plate, lag screw and cannulated screw were intact, the two (2) cortex screws were broken at the head.
Additional Manufacturer Narrative
Additional information provided.A review of the device history record could not be performed as the lot number provided is not valid for elmira.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.
Additional Manufacturer Narrative
Additional information provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial.
Event or Problem Description
Further it was reported that the two (2) cortex screws were broken at the head due to a traumatic event of fall.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent hardware removal of a one (1) dynamic hip screw (dhs) plate, one (1) dhs lag screw, two (2) cortex screws, one (1) 7.3 cannulated screw, and 1 washer due to a new traumatic event of fall that injured the hip and other areas.The hardware was implanted on an unknown date.All implants were successfully removed.The procedure was successfully completed with no surgical delay.Patient outcome is stable.This report is for one (1) dhs®/dcs® one-step lag screw 12.7mm thread/80mm.This is report 2 of 5 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.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.

• Brand Name: DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/80MM
• Common Device Name: APPLIANCE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7953909
• Report Number: 2939274-2018-54295
• Device Sequence Number: 19179134
• Product Code: KTT
• UDI-Device Identifier: 10886982175113
• UDI-Public: (01)10886982175113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/24/2018

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: 280.280
• Device Catalogue Number: 280.280
• Device Lot Number: 394480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 10/17/2018; 10/23/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/15/2018; 10/19/2018; 11/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 80