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

Device Problems Device Handling Problem (3265); Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - nails: tfna/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(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.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during the removal procedure, there was no chance or possibility to remove an unknown tfna nail or an unknown hip screw due to an unknown anti-rotation screw broke off and the "feeler" was blocking the hip screw.Thus, the procedure was unsuccessfully completed with 60 minutes of surgical delay.The implants remained in the patient's body.Patient status is unknown.Concomitant device reported: unknown tfna helical blade (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This complaint if for one (1) unk - nails: tfna.This report is 2 of 2 for (b)(4).

Event Description

It was reported that on (b)(6) 2019, during the removal procedure, there was no chance or possibility to remove an unknown trochanteric fixation nail advanced (tfna) nail and an unknown helical blade due to locking mechanism of tfna nail broke off and the "feeler" was blocking the helical blade.Thus, the procedure was unsuccessfully completed with sixty (60) minutes of surgical delay.The whole construct without locking screws remained in the patient's body.Date of original implant is unknown.Patient status is unknown.Concomitant device reported: unknown tfna helical blade (part# unknown, lot# unknown, quantity 1); unknown locking screws (part # unknown, lot # unknown, quantity unknown).This is report 1 of 1 for complaint (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.Updated event description and concomitant devices.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

Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity 1), unknown tfna helical blade (part# unknown, 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.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: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8805214
• MDR Text Key: 151556981
• Report Number: 8030965-2019-66399
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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: 09/13/2019
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention