MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 412.213S

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Lot number is unknown.It is unknown if device was implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unavailable.Reporter is a synthes sales consultant.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.(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 synthes europe reports an event in (b)(6) as follows: it was reported that the femoral neck system (fns) system was applied to the femur on (b)(6) 2018.When the surgeon tried to insert the locking screw, he attached the protection sleeve to the position (2-hole plate) of the insertion handle by mistake.He should have attached the protection sleeve to the ¿1-hole plate¿ position.Consequently, the location of the screw was deviated from the fns plate, and the screw went into the bone without being caught by the fns plate.The surgeon tried to remove the screw using a driver, but the screw was pushed by the driver shaft.Then, it reached at the opposite side of the bone.An additional incision with 1 cm length was made on the opposite side, and the screw was removed using forceps.The procedure was completed successfully with a delay of 120 minutes.Patient status is unknown.This report is for a 5.0mm titanium (ti) locking screw self-tapping with t25 stardrive 38mm-sterile.This is report 1 of 1 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.H11 corrected data: d6, d7: device malfunctioned intra-operatively and was not implanted / explanted.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.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7726760
• MDR Text Key: 115242272
• Report Number: 8030965-2018-55320
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819152342
• UDI-Public: (01)07611819152342
• Combination Product (y/n): N
• PMA/PMN Number: K000682
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.213S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention