MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPECIALTY LOCKING MEASURING DEVICE FOR TI FEMORAL NAILS-EX; GAUGE,DEPTH

Catalog Number 03.010.085

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

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 as no product was received.Investigation summary - the investigation could not be completed; no conclusion could be drawn.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an unknown procedure for a patient with a femoral shaft fracture, the guide wire and the direct measuring device for guide wires does not produce an effective screw length based on the surgical technique of the expert a2fn.It was also reported that the surgeon followed the procedure and found that the measured length of the hip screw using the 400 mm 3.2mm guide wire and the direct measuring device for guide wires were not the effective screw length, but 5mm shorter than measured.The surgeon used the correct instruments and measured an 85mm hip screw, then inserted this in the patient and found out that the hip screw was 5mm longer.So, the surgeon has to open an 80mm hip screw which was a shorter screw.The procedure was completed successfully.There was a surgical delay of ten (ten) minutes.Patient and procedure outcome was unknown.Concomitant device/s reported: expert a2fn nail ( part# 04.009.453s, part# 8149447, quantity), hip screw 75mm ( part# 04.003.025s, lot# 7519970, quantity 1), hip screw 85mm ( part# 04.003.027s, lot# 8232286, quantity 1).This complaint involves one (1) device.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complaint is confirmed as we are able to confirm complaint description based on the received pictures.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 (information or/and material), 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.

• Brand Name: SPECIALTY LOCKING MEASURING DEVICE FOR TI FEMORAL NAILS-EX
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8728515
• MDR Text Key: 149000444
• Report Number: 8030965-2019-65618
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819765726
• UDI-Public: (01)07611819765726
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.085
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention