MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM CORTEX SCREW 30MM; SCREW, FIXATION, BONE

Model Number	204.030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age or date of birth and weight are not available for reporting.Udi: (b)(4); lot number unknown.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a distal tibial osteosynthesis procedure was performed on (b)(6) 2018 using a 3.5mm proximal tibial plate and a 3.5mm cortical screw.The screw was placed and a flexion maneuver was performed to observe a lateral image on the intensifier, at which point the screw broke.The screw remains implanted in the patient's bone.There is no report of surgical delay or patient harm.The procedure was successfully completed.Concomitant devices reported: 3.5mm proximal tibial plate (part number unknown, lot number unknown, quantity 1) this is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7287149
• Report Number: 8030965-2018-51291
• Device Sequence Number: 2116616
• Product Code: HWC
• UDI-Device Identifier: 10886982145437
• UDI-Public: (01)10886982145437(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112583
• 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
• Report Date (Section B): 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204.030
• Device Catalogue Number: 204.030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1