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

Catalog Number 319.010

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

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 (b)(6) reports an event as follows: it was reported that during an open reduction internal fixation (orif) surgery for an ulnar proximal end fracture on (b)(6) 2019, the tip of the short stardrive screwdriver shaft seemed to be crushed.Due to this condition, an unknown screw could not be inserted into the bone with the use of the screwdriver shaft.Moreover, the screwdriver shaft spanned on the screw head without being caught in the recess, thus, an unknown torque device could not be applied to the screw.The depth gauge needle did not slide smoothly that caused the difficulty in measuring.The surgery was completed with a 30-minutes surgical delay.There was no adverse consequence to the patient reported.Concomitant devices: screw (part: unknown, lot: unknown, quantity: unknown), torque device (part: unknown, lot: unknown, quantity: 1).This report is for a depth gauge for 2.7mm & small screws.This is report 2 of 2 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8636320
• MDR Text Key: 145948073
• Report Number: 8030965-2019-64420
• 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: 04/24/2019

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: 319.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; UNK - TORQUE DEVICES