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

Device Problems Sticking (1597); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.The 510k: this report is for an unknown nail head elements/unknown lot.Part and lot number are unknown; udi number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that during surgery the connecting screw did not engage with the spiral blade.The screw appeared to be cross threaded.The surgery was prolonged about 5 minutes and was completed with using an alternative locking method.There was no patient harm.This report is for two (2) devices.This report is 2 of 2 for (b)(4).

Event Description

Device report from synthes on an event in (b)(6).

Manufacturer Narrative

Investigation summary: product has not been returned for product investigation and no article - and lot number was provided.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.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.

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.Date 3/28/2018 omitted on previous follow-up.Device used for treatment, not diagnosis.

• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7377821
• MDR Text Key: 103705281
• Report Number: 8030965-2018-52516
• Device Sequence Number: 1
• Product Code: JDS
• 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
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1