MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown pfna blade.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown pfna blade.Pma/510(k) number is not available.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 europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, during the procedure, aproximal femoral nail antirotation (pfna) nail was not possible to lock as it was not possible to place the locking bolt correctly with the aiming arm.It was noted also that it was not possible to place the blade correctly with the complained aiming arm, the blade hit the nail cranial.It was unknown if there was surgical delay.Patient and procedure outcome are unknown.Concomitant devices: radiolucent insertion handle : (part:03.010.405, lot: 8365827, quantity:1).This report is for one (1) unknown pfna blade.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

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

Corrected concomitant devices reported: bolt ø4.9 self-tap l38 tan green (part 459.380, lot unknown, quantity 1); bolt ø4.9 self-tap l38 tan green (part 459.360, lot unknown, quantity 1); radiolucent insertion handle (part 03.010.405, lot 8365827, quantity 1).

Event Description

Update: 4/4/2019 two (2) pfna were affected, both from two (2) different surgery's and two different surgeons.It was not possible to place the blade correctly with the complained aiming arm, and the blade hit the nail cranial.Updated concomitant devices reported: radiolucent insertion handle: (part:03.010.405, lot: 8365827, quantity:1).

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.Updated information.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

Additional concomitant devices: bolt (part 459.380, lot unknown, quantity 1); bolt (part 459.360, lot unknown, quantity 1); bolt (part 459.340, lot unknown, quantity 1).

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.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: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8181727
• MDR Text Key: 131156512
• Report Number: 8030965-2018-59185
• Device Sequence Number: 1
• Product Code: HSB
• 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,Followup,Followup
• Report Date: 09/21/2018

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
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 03/26/2019; 04/04/2019; 04/16/2019
• Supplement Dates FDA Received: 03/27/2019; 04/08/2019; 04/17/2019
• Patient Sequence Number: 1