MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.4MM VA LOCKING SCREW STARDRIVE 18MM; SCREW, FIXATION, BONE

Model Number	02.210.118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of infection is not known.Additional product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.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 patient, who was implanted with a synthes distal radius plate and screws on (b)(6) 2017, experienced an infection at the implant site.The patient was revised on (b)(6) 2017, when the plate was left implanted and four 2.4 mm variable angle locking screws were explanted.Four of the screws were replaced with three new screws (12 mm, 16 mm and 20 mm lengths x1 each).The patient's wound was cleaned out and the surgeon re-positioned and replaced the screws to get the better purchase of the patient bone.One of the screws was not replaced.The surgeon felt that making the construct more stable would be more beneficial for the patient than just cleaning the wound alone.There were no reports that the device had loosened, migrated, backed-out or malfunctioned.The patient was reported to be on steroids and be subsequently immunocompromised.The patient was reported to be stable at the end of the procedure.It is unknown if the infection has subsided.This report is for one (1) 2.4 mm va locking screw stardrive 18 mm.This is report 3 of 5 for (b)(4).

• Brand Name: 2.4MM VA LOCKING SCREW STARDRIVE 18MM
• 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: 7205655
• Report Number: 2939274-2018-50309
• Device Sequence Number: 722784
• Product Code: HWC
• UDI-Device Identifier: 10886982052957
• UDI-Public: (01)10886982052957(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/24/2017

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: 02.210.118
• Device Catalogue Number: 02.210.118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2017
• Initial Report FDA Received Date: 01/19/2018
• 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 Weight: 83