MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH UNK - SCREWDRIVERS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown this report is for one unknown screwdriver/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is company representative.(b)(4).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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, osteosynthesis surgery for a femoral diaphyseal fracture was performed using an expert antegrade femoral nail (afn).After inserting two screws in the distal area, the surgeon found by x-rays that one screw was not inserted completely.He removed the screw and drilled again, but he failed to re-insert another screw in the hole.He drilled through the remaining screw hole, however, the drill interfered with the nail.The surgeon inserted a screw into the hole from which he removed the screw.He hammered a screwdriver which was attached to the screw because the screw could not be inserted easily.A secondary fracture occurred after he hammered the screwdriver about 5 times forcefully.The surgeon wrapped the secondary fracture site with nesplon cable, a competitors device.Eventually, the distal locking process was done with only one screw.The surgery was delayed by approximately 30 minutes.Patient status is unknown this is report 3 of 5 for (b)(4).This report is for one unknown screwdriver.

Event Description

The broken radiolucent drive is captured on related complaint (b)(4).This report captures the secondary fracture and the distal screw which was not inserted completely.

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.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.

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.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.

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.H10 additional narrative: b5, e1: phone number.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

The broken radiolucent drive is captured on related complaint (b)(4).The secondary fracture is captured on related complaint (b)(4).This complaint captures the distal screw which was not inserted completely.This report is for an unknown screwdriver.This is report 3 of 6 for (b)(4).

• Brand Name: UNK - SCREWDRIVERS
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8819948
• MDR Text Key: 152013598
• Report Number: 2939274-2019-59341
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR