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

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

Patient Problems Rupture (2208); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date in (b)(6) 2018.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 the (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent hardware removal and fpl recon due to an acute ruptured right flexor pollicis longus.Initially, the patient was implanted with a two (2) column plate and screws in (b)(6) 2018.The patient is fit and well.The surgical procedure was successfully completed with no surgical delay.This report is for an unknown plate.This is report 1 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The complaint condition of the fpl (flexor pollicis longus) rupture could not be confirmed based on the available data.The received x-rays were reviewed by the medical safety officer.The plate appears to be positioned a bit too distal.Thus the distal ramp/edge of the plate is positioned more volar.This would place the distal edge of the plate deeper into the carpal canal (grey lines) and may make the fpl ride or pulley over it and could cause a rupture.There are no screw head issues.Product was not returned and no article- and lot number was provided, therefore no further evaluation is possible.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.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8479489
• MDR Text Key: 140809435
• Report Number: 8030965-2019-62472
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• 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: 04/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR