MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNSCR Ø4 SELF-DRILL L36/12 TAN GOLD; SCREW,FIXATION,BONE

Model Number	407.636
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Implant date is unknown.Explant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Address and telephone number not available.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 during unknown procedure on (b)(6) 2018, cannscr ø4 self-drill l36/12 tan gold screw itself damaged inside before use and another screw (same size and material) was used to complete the procedure.There was no patient harm.This is report 1 of 1 for (b)(4).

• Brand Name: CANNSCR Ø4 SELF-DRILL L36/12 TAN GOLD
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7645461
• Report Number: 8030965-2018-54681
• Device Sequence Number: 16531626
• Product Code: HWC
• UDI-Device Identifier: 10886982208415
• UDI-Public: (01)10886982208415
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 407.636
• Device Catalogue Number: 407.636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/28/2018
• Patient Sequence Number: 1