MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.005.422
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event: it is unknown when the event occurred.This report is for a screw - unknown lot.Additional product code hwc.Implanted/explanted date: unknown.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a tibial screw broke during a hardware removal and revision due to non-union.The patient was implanted with a screw in (b)(6) 2017.It was subsequently discovered on an unknown date that the patient had a non-union.Following which, the patient was brought to the operating room on (b)(6) 2017 for the hardware removal.The screw broke when the surgeon was extracting the screw.There is no information provided regarding the status of the patient and the procedure.This complaint is associated with maude report (b)(4).This complaint involves one (1) device.This report is for an unknown screw.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Complainant device is not expected to be returned for manufacturer review/investigation.Implanted in (b)(6) 2017; exact date is unknown.Explanted on (b)(6) 2017; exact date is unknown.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.(b)(4).
Event or Problem Description
This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• MDR Report Key: 7205460
• Report Number: 2939274-2018-50312
• Device Sequence Number: 11017016
• Product Code: HSB
• UDI-Device Identifier: 10886982085344
• UDI-Public: (01)10886982085344(10)UNKNOWNLOT
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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: 04.005.422
• Device Catalogue Number: 04.005.422
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 82