MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 40MM; SCREW,FIXATION,BONE

Model Number	214.840
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	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.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 on (b)(6) 2020, the patient underwent removal of a broken dhs (dynamic hip screw).The 4.5 cortex screw that was broken was 214.840.All implants were successfully removed.The patient status and procedure outcome are unknown.Concomitant medical products: unk - plates: dhs/dcs (part# 281.102, lot# unknown, quantity# 1).Unk - nail head elements: dhs/dcs lag screw (part# 280.950, lot# unknown, quantity# 1).Unk - screws: cortex (part# unknown, lot# unknown, quantity# unknown).This is report 01 of 01 of (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 40MM
• 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: 9716776
• Report Number: 2939274-2020-00872
• Device Sequence Number: 16225592
• Product Code: HWC
• UDI-Device Identifier: 10886982154699
• UDI-Public: (01)10886982154699
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.840
• Device Catalogue Number: 214.84
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention