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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

510k: this report is for unknown locking screw.Part and lot numbers are unknown; udi number is unknown.510k is not available device remains implanted in the patient and no plans to explant device at this time.Complainant part is not available for return patient and device code (b)(4) is for screw was placed out of bounds of the nail.The surgeon could not remove the screw and left it in place.The surgeon drilled another hole in the oval hole at the distal end to insert another locking screw, which changed the medical plan for the patient and led to a 20 minute surgical delay 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.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 (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, surgery for femoral diaphyseal fracture was performed using the surelock distal targeting device.Intraoperatively, two events were confirmed by the surgeon.The drill bit hit the nail.The insertion of locking screw 5.0 mm/34mm was successful at the second hole from the distal end.However, the drill bit hit the nail when drilling at the most distal oval hole.A locking screw 5.0mm/36mm was inserted at the oval hole.Secondarily, the surgeon confirmed under the image that this locking screw 5.0mm/36mm, which was inserted at the oval hole, was being out of bounds (not inserted to the screw hole).He could not remove this screw, so he left the screw in the bone.Then, by using radiolucent drive, he drilled at the oval hole and inserted a locking screw at the distal far end.The surgery was completed with a 20-minute delay, and there was no adverse consequence to the patient.Concomitant devices: drill bit (part# 03.010.061, lot# unknown, qty 1) , screws (part# unknown, lot# unknown, qty unknown) , locking screws (part# unknown, lot# unknown, qty unknown) , femoral nail (part# unknown, lot# unknown, qty 1).This is report 5 of 5 for (b)(4).This report is for an unknown locking screw.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Patient identifier reported as ni in initial medwatch.Patient identifier is not available for reporting.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: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7303638
• MDR Text Key: 101238469
• Report Number: 8030965-2018-51528
• Device Sequence Number: 1
• Product Code: HWC
• 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: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR