MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.528S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.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.
Event or Problem Description
It was reported that on (b)(6) 2018, during hip surgery, upon insertion of a titanium interlocking screw into a trochanteric fixation nail advanced (tfna) nail, the head of the screw broke off.The head of the screw was successfully removed from the patient.It is unknown if there was a surgical delay.There was no patient consequence.Concomitant medical product: tfna nail (part# unknown, lot# unknown, quantity 1).This report is for one (1) 5.0mm ti locking screw.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER
• 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: 8188268
• Report Number: 2939274-2018-55510
• Device Sequence Number: 1901067
• Product Code: HWC
• UDI-Device Identifier: 10886982085979
• UDI-Public: (01)10886982085979
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 04.005.528S
• Device Catalogue Number: 04.005.528S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 77