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

Catalog Number 02.211.014

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient age or date of birth and weight not available for reporting.Additional product code: hrs.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Without a lot number the device history records review could not be completed.Subject device has been received and is currently in the evaluation process.(b)(4).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 during an open reduction internal fixation (orif) of the fibula procedure on (b)(6) 2017, while using a variable angle (va) distal fibula plate, the locking screws would not lock onto the plate.The surgeon used different locking screws on different locking holes on the plate to complete the surgery.There was a five (5) minute delay.The procedure was completed successfully.The patient status is unknown.This report is for one (1) 2.7 mm va locking screw.This is report 3 of 5 for (b)(4).

Manufacturer Narrative

Customer quality (cq) engineering investigation: this complaint was unable to be confirmed at cq.Visual inspection at cq showed the returned 4 screws show minor wear commensurate with attempted insertion into a locking plate.However, the plate used was not returned and no evidence was provided that proves that the screws did not lock to the plate as intended.The complaint was not able to be replicated at customer quality (cq) as the plate used in the intraoperative event was not returned.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification and drawing review were performed at cq for the returned device as part of this investigation.No product design issues or discrepancies were observed.Visual inspection at cq showed the returned 4 screws show minor wear commensurate with attempted insertion into a locking plate.A review of the device history records was unable to be performed since the lot numbers were unknown.Tabulated drawing for the family of 2.7mm self-tapping variable angle locking screws with stardrive recess was reviewed during this investigation.No product design issues or discrepancies were observed.A material check was not performed at cq as there is no indication that the material would have contributed to this complaint.The screw head major thread diameter of the 4 returned screws were measured at cq and ranged from 3.33mm - 3.35mm which is within specification of 3.30mm - 3.40mm per tabulated drawing.Unable to determine a definitive root cause as this complaint is unconfirmed.It is possible that the allowable variable angle of insertion was exceeded, or torque limiter was not used.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 14MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6893312
• MDR Text Key: 87861588
• Report Number: 1719045-2017-10978
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1