MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE,DEPTH

Catalog Number 319.010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an unknown procedure wherein a distal fibula plate was applied.When a depth gauge was used, the dial portion which is the connection point between the needle portion and outer sleeve of the device, could not be passed through the incision on the skin.The surgeon made the incision longer to pass the dial portion through it.The surgeon requested to make the needle portion of the gauge longer so that it becomes unnecessary to insert dial portion under the skin.The surgery was completed within a thirty (30) minute delay.There was no adverse consequence to the patient.Concomitant devices reported: unknown distal fibula plate (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8287383
• MDR Text Key: 134450038
• Report Number: 8030965-2019-60476
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819020733
• UDI-Public: (01)07611819020733
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 319.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention