MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM; SCREW, FIXATION, BONE

Model Number	02.226.020
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Date of event: unknown.Implant date: 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.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
It was reported that a patient was implanted with a 3.0 mm headless compression screw and three (3) other unknown synthes screws on an unknown date at the first proximal phlange.Patient complained of pain on an unknown date along noticeable visibility of the screw pressing upon the skin.X-rays were taken on an unknown date showing one of the four screws backing out.Patient underwent surgery on (b)(6) 2018 to remove the one screw that was backing out.The screw was removed easily.The other three (3) screws had no issues and remained intact.Routine intraoperative x-rays were taken.The patient was not revised to any additional hardware and had achieved union.There was no surgical delay.The procedure was completed successfully and the patient was reported as stable.Concomitant devices reported: unknown synthes screws (part unknown, lot unknown, quantity 3).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.

• Brand Name: 3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7266926
• Report Number: 8030965-2018-51071
• Device Sequence Number: 11176565
• Product Code: HWC
• UDI-Device Identifier: 10886982057860
• UDI-Public: (01)10886982057860(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K050636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.226.020
• Device Catalogue Number: 02.226.020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR