MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 38MM; SCREW, FIXATION, BONE

Model Number	214.838
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Product was not returned.The investigation could not be completed; no conclusion could be drawn.Investigation summary 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.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported a patient underwent a hip surgery on (b)(6) 2018, one (1) cortex screw self-tapping broke near the head of the screw while power driving into the left femur.The screw already had bicortical purchase, no clinical significance, and left intact, eight (8) total cortices purchased, stable for fixation.It is unknown if there was surgical delay.Patient and procedure outcome is unknown.Concomitant devices reported: unknown cortex screws (part #, lot #, quantity 7).This complaint involves one (1) device.This report is 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product code: ktt.Device was used for treatment, not diagnosis.

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 38MM
• 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: 8081813
• Report Number: 2939274-2018-55018
• Device Sequence Number: 1691771
• Product Code: HWC
• UDI-Device Identifier: 10886982154682
• UDI-Public: (01)10886982154682
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.838
• Device Catalogue Number: 214.838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/16/2018
• Patient Sequence Number: 1