MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM; GAUGE, DEPTH

Catalog Number 319.150

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that during an unknown surgical procedure on an unknown date, the cannulated screw measuring device was discovered to be measuring 2.5mm too long.It was noted that the threaded guide wire (kirschner wire) was the right sort and was used as it was the correct length.A new cannulated screw measuring device was ordered and received the same result of measuring 2.5mm too long.No patient consequence was reported.Concomitant devices: cannulated screw (part unknown, lot unknown, quantity 1), 1.25mm threaded guide wire 150mm (292.620, lot unknown, quantity 1).This report is for one (1) cannulated screw measuring device.This is report 2 of 2 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated event description.Device was used for treatment, not diagnosis.

Event Description

On 11/19/2018: updated event description: it was reported that on (b)(6) 2018, during an unknown procedure, the direct measuring device was used for the first time to a new placement cannulated screw and was discovered that measuring was too long.It was noted that the k-wire with the right sort where used and was the correct length.A new direct measuring device was ordered and showed exactly the same result, which was too long.There was no patient consequence reported.

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.Additional narrative: therapy date.A device history record (dhr) review was conducted: part: 319.150.Lot: l016909.Manufacturing site: hägendorf.Release to warehouse date: 18.Aug.2016.The device history record shows this lot of 23 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Corrected data: complainant part is not expected to be returned for manufacturer review/investigation.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.

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.Additional 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.

• Brand Name: CANNULATED SCREW MEASURING DEVICE FOR 3.5MM & 4.0MM
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8075454
• MDR Text Key: 127548966
• Report Number: 8030965-2018-58267
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819020818
• UDI-Public: (01)07611819020818
• 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,Followup,Followup
• Report Date: 10/17/2018

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
• Device Catalogue Number: 319.150
• Device Lot Number: L016909
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 01/16/2019; 01/22/2019
• Supplement Dates FDA Received: 12/10/2018; 01/17/2019; 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1