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

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unk - screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 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 during the intra-op event on (b)(6) 2019, the surgeon had used two-column plates for at least 4 years, but especially this year, he faced the events like screwdriver shafts stripping screws several times.There was no surgical delay.No patient consequence.Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity unknown), unknown torque limiter (part # unknown, lot# unknown, quantity 1), unknown torque limiter handle (part # unknown, lot# unknown, quantity 1).This is report 2 of 2 for (b)(4).Related to (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9577025
• MDR Text Key: 190634795
• Report Number: 8030965-2020-00247
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• 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