MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unk - screws: locking/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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) 2019, the patient underwent open reduction internal fixation surgery for right distal radius fracture with two-column plate, va locking screws, ti locking screws and the screwdriver shafts.During the inserting the screws, the surgeon used the screwdriver shafts, but the screwdriver shafts stripped all screws because the screwdriver shafts bit with the screw head shallowly.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.Concomitant device reported: torque limiter (part # 511.776, lot# unknown, quantity 1), torque limiter handle (part # 03.110.005, lot# unknown, quantity 1), unknown plate (part # unknown, lot # unknown, quantity unknown).This is report 2 of 3 for (b)(4).Related product complaint (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.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

Updated ed: this pc is related to (b)(4) which reports that a few events about screwdriver shafts which the surgeon faced this year.This pc reports that the screwdriver shafts stripped the screws on (b)(6) 2019.It was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for right distal radius fracture with two-column plate, va locking screws, ti locking screws and the screwdriver shafts in question.During the inserting the screws, the surgeon used the screwdriver shafts, but the screwdriver shafts stripped all screws because the screwdriver shafts bit with the screw head shallowly.There was no surgical delay.The surgeon commented as follows.The surgeon had used two-column plates for at least 4years, but especially this year, he faced the events like this case several times (reported by (b)(4)).The surgeon was afraid that the screwdriver shaft stripped the screw head because he supposed the screw removal.Doesn¿t the star-shaped originally improve the connection between the screwdriver shaft and the screw head? the surgeon wanted to know that how often the screwdriver shafts were replaced, and generally how many operations they were used in.Concomitant device reported: torque limiter (part # 511.776, lot# 24251, quantity 1), torque limiter handle (part # 03.110.005, lot# 9064923, quantity 1), unknown plate (part # unknown, lot # unknown, quantity unknown).

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9575967
• MDR Text Key: 194654849
• Report Number: 8030965-2020-00237
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Patient Sequence Number: 1
• Treatment: HANDLE F/TORQUE LIMITERS 0.4/0.8/1.2NM; TORQUE LIMITER 0.8NM W/AO/ASIF-QC; UNK - PLATES