MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 20MM; NAIL,FIXATION,BONE

Model Number	212.106
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient id (b)(6).Patient weight was not provided for reporting.Additional device procode: ktt.Device remained implanted.Device explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture the surgeon used stainless steel screws with a titanium plate due to the titanium screw were not available.The mixing of metals can cause metallosis.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent procedure for osteosynthesis distal tibia and right fibula.Reportedly, lcp 3.5 mm plates for distal tibia in titanium and steel with their respective screw racks were sent for this procedure.The tibial osteosynthesis procedure was started with a very distal fracture.A 6-hole right medial plate was placed in titanium and fixation was started in the distal part.The doctor needed a blocked screw of 3.5 mm of 14 mm but the screws in titanium rack started from 26 mm up to 60 mm in length; the doctor was upset and placed a 3.5 mm x 14 mm locked screw in steel, since steel screws come from 10 mm to 60 mm in length.Fixation was continued and in the body of the plate the doctor decided to place a blocked screw of 3.5 mm x 20 mm, but again a screw locked of 3.5 mm x 20 mm in steel was placed due to the missing titanium screw of 3.5 mm x 20 mm length in the titanium screw rack.Fixation of the fibula was performed without problems.Because of this event, the doctor was upset and made the observation of the conflict of materials that can produce metallosis.Concomitant devices reported: 6-hole right medial plate (part # 04.112.514, lot # 41016787, qty 1).This report is for one (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 20mm.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Concomitant medical products: 6-hole right medial plates ( 04.112.514, lot # unknown, qty, 3).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 20MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7241118
• Report Number: 8030965-2018-50853
• Device Sequence Number: 16399529
• Product Code: JDS
• UDI-Device Identifier: 10886982151803
• UDI-Public: (01)10886982151803(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2018

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: 212.106
• Device Catalogue Number: 212.106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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: 72 YR