MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SCREW, FIXATION, BONE

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.This report is for one (1) unknown variable angle (va) locking screw.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.It is unknown if the screw was implanted or not.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for screw is not provided.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a surgery for distal radius fracture on (b)(6) 2018, surgeon inserted three (3) screws on the most distal holes for fixation of variable angle (va) tcp small plate 3 holes.After guiding block was taken out from the plate, va locking screw was inserted at a variable angle with the help of variable angle-locking compression plate (va-lcp) drill sleeve; however, the va locking screw could not be tightened at all.The surgeon tried to insert another screw to the same hole of the plate, but it could not be tightened, too.The surgeon thought the thread of plate hole had been damaged, so he decided that the surgery was completed without inserting screw to the hole of plate as he confirmed the plate fixation.Procedure was completed successfully.There was no adverse consequence to the patient and no delay to the surgery.Concomitant device reported: va-lcp drill sleeve (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown variable angle (va) locking screw.This is report 3 of 3 for complaint (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7327885
• MDR Text Key: 102017426
• Report Number: 8030965-2018-51905
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1