MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; SCREW, FIXATION, BONE

Model Number	04.214.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient case number reported as (b)(6).Additional procode: hrs.Lot number is unknown.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 phone number and email address are unknown.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.(b)(4).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: during an implant placement procedure on (b)(6) 2018, the heads of two titanium (ti) cortex screws broke due to the worn tip of two (2) stardrive screwdriver shafts.All device fragments were easily removed and new screws were implanted to the patient.The procedure was completed successfully with a reported delay of forty five (45) minutes.There is no other reported patient consequence.This report is for a 1.5mm ti cortex scr slf-tpng with t4 stardrive recess 10mm.This is report 4 of 4 for (b)(4).

• Brand Name: 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7681273
• Report Number: 8030965-2018-54959
• Device Sequence Number: 1452655
• Product Code: HWC
• UDI-Device Identifier: 10886982120854
• UDI-Public: (01)10886982120854
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 04.214.110
• Device Catalogue Number: 04.214.110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/12/2018
• Patient Sequence Number: 1