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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE PLATE, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.211.201S
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient information is not available for reporting. (b)(4). Device remained implanted; as such explant date is not applicable. Complainant device is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was performed: part no: 04. 112. 201s, lot no: l725498: manufacturing location: (b)(4), release to warehouse date: 02. Feb. 2018, expiry date: 01. Jan. 2028: no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 synthes europe reports an event in (b)(6) as follows: it was reported that arthrodesis was applied to hallux valgus on (b)(6) 2018. During fixation to variable angle (va) x plate, va locking screw span around, and was not locked to the plate. Because the surgeon could not remove the screw for replacement, he left the screw as it was and completed the surgery with a 30-minute surgical delay. The surgeon commented that at first it was hard to insert the screw in question, and in the middle, it was light to insert it and then the screw spin. Also, he pointed out that setting of torque limiter might have been more excessive than he expected. No other medical intervention required. Patient outcome reported as okay. This report is for one (1) 2. 4/2. 7mm ti va locking x-plate. This is report 2 of 2 for complaint (b)(4).

 
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Brand Name2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7515466
MDR Text Key108358709
Report Number8030965-2018-53770
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK100776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number04.211.201S
Device LOT NumberL725498
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/02/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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