MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP OLECRANON PLATE; PLATE, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: lcp olecranon plate/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of olecranon of left ulna.To fix the spoon part of a plate with the locking screw, a drill sleeve for angle fixation was used to drill, and then the screw insertion proceeded.The locking screw got idle rotation and did not lock.Even though there was a creaking metallic sound, the locking screw was not engaged deeper with a plate hole.The surgeon replaced the screwdriver with a different one and tried to lock the locking screw again, but it did not go well, and in the end, the surgeon determined to finish fixing without torque.The surgery was completed successfully within 30 minutes delay.No further information is available.Concomitant devices reported.Unknown screwdriver (part# unknown, lot# unknown, quantity# 2).Unknown drill sleeve (part# unknown, lot# unknown, quantity# 1).This complaint involves (2) devices.This report is for (1) unk - plates: lcp olecranon plate.This report is 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES: LCP OLECRANON PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12218521
• MDR Text Key: 265180550
• Report Number: 8030965-2021-06050
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/23/2021
• 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