MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS; GAUGE,DEPTH

Catalog Number 319.700

Device Problem Incorrect Measurement (1383)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, 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) 2018, during an open reduction internal fixation procedure, the direct measuring device showed a discrepancy in measurement.The guide wire inserted into the patient¿s body was measured with a direct measuring device.The indication on the measuring device was 5mm longer than the actual (correct) length.An implant was selected based on the measured value and inserted into the patients body.However, due to the discrepancy between the actual and measured values, the implant was longer than the proper length.Thus, the surgeon had to replace the implant with another one of correct size.The surgery was completed with a 30-minute surgical delay.There was no adverse consequence to the patient.Concomitant device reported: unknown guide wire (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) cann screw measuring device for 6.5mm & 7.3mm cann screws.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.Corrected data: initial reporter title and name.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.Device history lot.Part: 391.700.Lot: 8871942.Manufacturing site: (b)(4).Release to warehouse date: 28.Mar.2014.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional 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.Visual inspection: the received direct measuring device is in used but still faultless condition.Functional test: carried out functional test was passed successfully the received device is in complete faultless condition and shows correct screw length.No product fault could be identified.Therefore we cannot replicate the complained condition.This complaint is classified as not confirmed.No further investigations are required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8038129
• MDR Text Key: 126113197
• Report Number: 8030965-2018-57913
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819064850
• UDI-Public: (01)07611819064850
• 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
• Report Date: 10/18/2018

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: 319.700
• Device Lot Number: 8871942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/13/2018; 12/06/2018
• Supplement Dates FDA Received: 11/30/2018; 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention