MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/24MM; SCREW, FIXATION, BONE

Model Number	02.206.224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unavailable.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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 during a distal tibial fracture reduction on (b)(6) 2018, a cortex screw broke upon introducing the screw into a diagonal force to generate screw axis.Surgical outcome and patient status is unknown.This report is for a 3.5mm cortex screw/low profile head self-tapping/star drive/24mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7837382
• Report Number: 8030965-2018-56109
• Device Sequence Number: 1175112
• Product Code: HWC
• UDI-Device Identifier: 10886982051028
• UDI-Public: (01)10886982051028
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 02.206.224
• Device Catalogue Number: 02.206.224
• Device Lot Number: 6788516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1
• Patient Age: 51 YR