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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown femoral plate/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date in (b)(6) 2012.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that a patient underwent an unknown procedure on (b)(6) 2018, to treat a femoral trochanteric fracture.Patient was initially implanted with a locking compression plate (lcp) distal femur plate in (b)(6) of 2012.The original plan of surgery was to remove the lcp plate and implant a long nail.During the procedure, the four (4) screws on the proximal part of the plate were successfully removed.However, only one (1) out of the five (5) screws on the distal part was removed because the head of the other four (4) screws were stripped and could not be removed from the plate.The surgeon tried to remove the screws using a conical extraction screw but the tip of it broke off, and the broken piece remained in one of the screw heads.Since the broken piece of the extraction screw protruded from the screw head, it was cut with a carbide drill.The surgeon decided to leave the four (4) stripped screws with the plate in the patient.The trochanter was fixed with a short nail.There was a 40-minutes surgical delay reported.Patient status is unknown.Concomitant devices: screws (part: unknown, lot: unknown, quantity: 5), drill (part: unknown, lot: unknown, quantity: 1).This report is for an unknown femoral plate.This is report 2 of 3 for (b)(4).

• Type of Device: PLATE, 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: 8191131
• MDR Text Key: 131206467
• Report Number: 8030965-2018-59226
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• 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: 11/26/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR