MAUDE Adverse Event Report: SYNTHES USA PRODUCTS LLC 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/22MM; SCREW, FIXATION, BONE

Model Number	02.206.222
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.(b)(4).Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Investigation summary: product was not returned.The device history review revealed no complaint related anomalies or non-conformance.Based on the information available, 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.
Event or Problem Description
It was reported that the patient underwent revision of a 1 plate, 4 cortex screw.4 variable angle locking compression screw and 1 metaphyseal screw on (b)(6) 2017 due to right tibial infection.The plate and screws were originally implanted on an unknown date.The devices were removed intact and an antibiotic nail was implanted.The surgery was successfully completed with no delay.The patient outcome was reported as fine.The patient may be scheduled for additional surgeries as part of a staged re-implantation.This complaint is for ten (10) devices.(b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial.

• Brand Name: 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7194035
• Report Number: 2939274-2018-50274
• Device Sequence Number: 13919174
• Product Code: HWC
• UDI-Device Identifier: 10886982051004
• UDI-Public: (01)10886982051004(10)LOTNUMBERUKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K111230
• 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,Followup
• Report Date (Section B): 12/20/2017

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: 02.206.222
• Device Catalogue Number: 02.206.222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/12/2018
• 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: 60