MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; PLATE,FIXATION,BONE

Catalog Number 02.211.020

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code hwc.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.Device history lot.Part number: 02.211.020, synthes lot number: 15l0479, manufactured by jabil inc.-(b)(4).A dhr file from the time of manufacture could not be reviewed because it is not been scanned into tungsten yet.Device history review: jde confirmed that the lot was released for sale in september 2019.A search in mdd nonconformance module confirmed that no non-conformances occurred during manufacture.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 on an unknown date that during an unknown surgery, two of the most distal holes in the medial plate do not allow the screws to approach the locking hole with a variable angle.Therefore, the client decides to leave the implanted plate and fasten with the other remaining holes.There was no reported delay.The patient outcome was unknown.This complaint involves four (4) devices.This is report 2 of 4 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester ; SZ ; 6103142063
• MDR Report Key: 9953678
• MDR Text Key: 187415752
• Report Number: 8030965-2020-02828
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819424968
• UDI-Public: (01)07611819424968
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K103243
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.020
• Device Lot Number: 15L0479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2020
• 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
• Treatment: 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; VA-LCP DHP 2.7/3.5 MED R MED 2HO L82 SST