MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED SCREW 16MM THREAD/90MM; SCREW,FIXATION,BONE

Model Number	208.890
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
Initial reporter phone number: (b)(6).(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent hardware removal due to proximal femur fracture loss of reduction with dynamic hip screw system (dhs) + cannulated screw and was revised to total hip.The procedure outcome and patient's status are unknown.This complaint involves three (3) devices.This report is for (1) 7.3mm cannulated screw 16mm thread/90mm.This is report 3 of 4 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.D10, h3, h6: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 7.3MM CANNULATED SCREW 16MM THREAD/90MM
• 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: 10629158
• Report Number: 2939274-2020-04490
• Device Sequence Number: 11488361
• Product Code: HWC
• UDI-Device Identifier: 10886982150011
• UDI-Public: (01)10886982150011
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2020

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: 208.890
• Device Catalogue Number: 208.890
• Device Lot Number: L940669
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Received by Manufacturer: 09/13/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention