MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CORTSCR Ø3.5 L30 SST; 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	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient age, date of birth and weight were not available for reporting.Device is not considered implanted or explanted as device fragments were generated and not removed.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is the company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an unknown procedure on (b)(6) 2018, while placing the 3.5 mm cortex screws with a compact drive, the heads of two screws broke.The screws heads were left in the patient bone.There was no surgical delay or patient harm reported.The procedure was completed successfully.This is report 2 of 2 for (b)(4).

• Brand Name: CORTSCR Ø3.5 L30 SST
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7317664
• Report Number: 8030965-2018-51764
• Device Sequence Number: 11164118
• Product Code: HWC
• UDI-Device Identifier: 10886982145437
• UDI-Public: (01)10886982145437(10)LOTNUMBERUNKNOWN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: 02/07/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1