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 Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

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, an open reduction internal fixation (orif) surgery for a distal radius fracture was performed.During surgery, the depth gauge did not slide smoothly.The inner section with the scale did not slide through the outer cylinder of the depth gauge.There was a surgical delay of less than 30 minutes.There was no adverse consequence to the patient.Surgical outcome is unknown.This report is for one (1) depth gauge for 2.0mm/2.4mm and 2.7mm 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device evaluated by mfr: part: 03.111.005; lot: 7852685; manufacturing site: haegendorf; release to warehouse date: april 26, 2012.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.Investigation site: cq zuchwil; selected flow: 2.Device interaction/functional.Visual inspection shows that the measuring hook is slightly bent backwards.This may have caused the described problem.Therefore, we classify this complaint as confirmed as the received condition agrees with complaint description.Despite this damage, after applying one drop of synthes oil, the parts can be moved without any force.Please note, all movable parts most be oiled with synthes oil after each use.Functional test: after lubrication, all parts could be moved as intended.Even though this device is several years old and was often in use, it is still in faultless condition and the function is as intended.As the problem was solved after regular maintenance very easily, no further investigations are required.No product fault could be identified.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: 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: 7947843
• MDR Text Key: 123360898
• Report Number: 8030965-2018-57113
• 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
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• 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: 7852685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1