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

Device Problem Device Operational Issue (2914)

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

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.510k: this report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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 on an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the operation was performed with the va locking hand system.During surgery, the locking y-plate 1.3 (part number: unk) was bent with the bending pliers.The surgeon drilled the threaded cannula and attempted to use the locking screw (part number: 04.130.108s, lot no: 9837813) after measuring the screw length.It was determined that the screw head was idling after touching the lock y-plate and another new lock screw was also rotating at idle.The operation was completed with a 10-minute delay, although it was not reported on how the operation was completed, and there were no adverse consequences for the patient.Complaint involves one part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Complained device was not returned for investigation.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.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7294185
• MDR Text Key: 101019327
• Report Number: 8030965-2018-51362
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/24/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1