MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 26MM; SCREW,FIXATION,BONE

Model Number	204.826
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Id-case no.(b)(4).Date of event is unknown.Additional classification code: hrs, jds.Implant date is unknown.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.The manufacture date is unknown.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 patient underwent hardware removal surgery on (b)(6), 2017 due to a refractured ankle.The patient originally underwent an open reduction internal fixation (orif) of the left ankle and was implanted with a cancellous bone screw, 3 cortex screws, and a tubular plate on an unknown date in (b)(6) 2017.However, sometime last week, the patient tripped on a curb and refractured his left ankle.The results of the hardware removal surgery were successful, the patient was reported to be in excellent condition.All the originally implanted hardware was replaced with new implants.There was no reported surgical delay.All available information was received from the sales consultant.This is report 4 of 5 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 26MM
• 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: 7110040
• Report Number: 2939274-2017-50224
• Device Sequence Number: 1145619
• Product Code: HWC
• UDI-Device Identifier: 10886982146311
• UDI-Public: (01)10886982146311(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.826
• Device Catalogue Number: 204.826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/12/2017
• 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: 34 YR
• Patient Weight: 134