MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 3.5MM TI CORTEX SCREW 32MM; SCREW, FIXATION, BONE

Model Number	404.032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(6).(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded.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 reports an event in (b)(6) as follows: it was reported during a proximal humerus osteosynthesis procedure, the doctor placed a screw in the very angled distal fragment and during the final adjustment with the screwdriver, the screw broke.A piece of the screw remained in the patient¿s bone.Reportedly there was no surgical delay.Concomitant device: screwdriver (part/lot unknown, quantity 1).(b)(4).

• Brand Name: 3.5MM TI CORTEX SCREW 32MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• MDR Report Key: 7113395
• Report Number: 8030965-2017-50613
• Device Sequence Number: 1298126
• Product Code: HWC
• UDI-Device Identifier: 10886982207036
• UDI-Public: (01)10886982207036(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 404.032
• Device Catalogue Number: 404.032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 70