MAUDE Adverse Event Report: SYNTHES USA 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW,FIXATION,BONE

Catalog Number 02.211.018

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional device product code: hrs.(b)(4).Without a lot number the device history records review could not be completed.A product investigation was performed.This complaint is confirmed.Surgeon reported that the "plate/screw failed".One plate was received at customer quality (cq) in 2 pieces.The break is transverse and located in the middle third of the plate in the center of the elliptical hole used for guide wires.The 6 returned screws show wear associated with implantation and explantation but are all intact.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned plate is already broken.No new malfunctions were identified.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Relevant drawing was reviewed during this investigation.Based on visual inspection under 5x magnification, measurements at cq with calipernd with reference to product drawing 02_211_008, the 6 returned unknown screws were able to be definitively determined as the following.Qty (1) of 02.211.014, unknown lot#; qty (3) of 02.211.018, unknown lot#; qty (1) of 02.211.022, unknown lot#; qty (1) of 02.211.024, unknown lot#.Unable to determine a root cause based on the complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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

It was reported that the patient had an original surgery procedure done for a metatarsophalangeal joint on an unknown date where a variable angled (va) 2.4mm/2.7mm locking compression plate (lcp), right and 6 screws were implanted.Surgeon reported that the plate/screw failed.Patient is scheduled to have follow up surgery on (b)(6) 2017.This is report 3 of 7 for complaint (b)(4).

Manufacturer Narrative

Date received by manufacturer reported incorrectly on medwatch report (b)(4).The date should be march 27, 2017.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.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6449923
• MDR Text Key: 71396391
• Report Number: 2520274-2017-11133
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention