MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: 4.5 MM CANNULATED; SCREW, FIXATION, BONE

Device Problems Crack (1135); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown 4.5 mm cannulated screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: sabnis, b., brenkel, i., chesney, d., and weir, i.(2009), unusual mode of mechanical failure of an ao cannulated self drilling screw.A case report, acta orthopaedica belgica, vol.75 (4), pages 557-560 (united kingdom).This study presents a case report of a (b)(6) year-old female patient who sustained a supination-adduction injury with a vertical fracture of the medial malleolus and a salter harris type ii injury to the lateral malleolus.Surgery was performed using an ao 40 mm long 4.5 mm cannulated cancellous self drilling screw.During insertion of screw, unusual resistance was felt while the screw was halfway in.Fluoroscopy revealed an unusual picture -unwinding of threads of the screw with the threaded region migrating perpendicular to the line of the screw fixation.The fracture was fixed with another screw before attempting removal of the affected screw.As the screw was withdrawn gently, the threads were seen to be winding again over the guide wire and the screw was removed without any difficulty.The fracture was fixed with one more screw in a satisfactory position.The removed screw showed a continuous split along the root diameter in a spiral manner corresponding to the troughs of the threaded region.This is report 1 of 1 for (b)(4).This report is for an unknown synthes 4.5 mm cannulated screws.

• Brand Name: UNK - SCREWS: 4.5 MM CANNULATED
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9878825
• MDR Text Key: 190493750
• Report Number: 8030965-2020-02287
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1