MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS; GAUGE, DEPTH

Catalog Number 03.111.005

Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

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.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.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, before the surgery, the nurse found that the depth gauge that was delivered did not move smoothly at all.It was confirmed that the depth gauge could not be used in the surgery.Another set was delivered to be used to complete the procedure.There was no adverse consequence to the patient.Procedure was completed successfully.This report is for one (1) depth gauge for 2.0mm/2.4mm and 2.7mm screws.This is report 1 of 1 for complaint (b)(4).

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.

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated event description provided for reporting.Investigation summary investigation site: zuchwil selected flow(s): 2.Device interaction/functional visual inspection: the visual inspection shows that the measuring hook is badly bent and visible signs of wear are visible.Functional test / dimensional inspection: the functional test was performed.Since the measuring hook is badly bent it cannot be moved smoothly due to the damage incurred.In addition, a function test was performed at the time of manufacturing with no issues documented.Document/ specification review: the device history record shows this lot of 40 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, material and visual criteria at the time of release with no issues documented during the manufacturing process.No nc's were generated during the production of the lot in question.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Since the measuring hook is badly bent it cannot be moved smoothly due to the damage incurred.This lot of 40 pieces was manufactured in march 2015.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.The exact cause of this complaint cannot be determined.We assume that the depth gauge was subjected to improper handling and this could have led to the bending.Base on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.H3,h4, h6: device history part: 03.111.005 lot: 9371442 manufacturing site: haegendorf release to warehouse date: 09.Mar.2015 the device history record shows this lot of 40 pieces 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.Device history batch null, device history review 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.Device was used for treatment, not diagnosis.

Event Description

(b)(6) 2019: updated event description: it was reported that on november 16, 2018, before the surgery, the nurse discovered that the depth gauge that was delivered, did not function as expected and could not be used in the surgery.Another set was delivered to be used in the procedure.There was no patient nor surgical involvement.This complaint involves one (1) device.

• Brand Name: DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8127082
• MDR Text Key: 129152588
• Report Number: 8030965-2018-58717
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819356344
• UDI-Public: (01)07611819356344
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.111.005
• Device Lot Number: 9371442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1