MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; PLATE,FIXATION,BONE

Catalog Number 02.211.014

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.Nvestigation 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: 02.211.014.Synthes lot number:11l8041.Manufactured by jabil inc-monument.A dhr file from the time of manufacture could not be reviewed because it is not been scanned into tungsten yet.Jde confirmed that the lot was released for sale in august 2019.Device history review.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 4 of 4 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
• 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 19380 ; 6103142063
• MDR Report Key: 9953677
• MDR Text Key: 187796573
• Report Number: 8030965-2020-02831
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819424937
• UDI-Public: (01)07611819424937
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.014
• Device Lot Number: 11L8041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1