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

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).

• Brand Name: 2.4/2.7MM TI VA LCKNG X-PLATE EXTRA SMALL-STERILE
• Type of Device: PLATE, 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 Key: 7515466
• MDR Text Key: 108358709
• Report Number: 8030965-2018-53770
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819445123
• UDI-Public: (01)07611819445123
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• 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

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: 04.211.201S
• Device Lot Number: L725498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/15/2018
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1