MAUDE Adverse Event Report: SYNTHES USA; PLATE, FIXATION, BONE

Device Problem Material Fragmentation (1261)

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

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown metallic fragment.It is unknown if the fragments were generated from the screws or the plate.Possible additional device product code: hwc.It is unknown if the fragments were generated from the explanted screws or from the implanted the plate.As such implant/explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the reported devices were used in hallux valgus correction surgery on (b)(6) 2016.The surgeon implanted a va (variable angle) locking plate and three locking screws.He did a final check after he concluded with a driver.It was needed to change the rotation; therefore he extracted two of the screws and changed them.As he removed the screws, surgeon stated that torque was too strong and, moreover the extraction was very hard even though it was just right after he inserted the screw.Further while removing the screw a metallic fragments like lint came out from the variable angle hole.Surgery was prolonged for 2 minutes due to reported issues.There is no information available about patient and surgical outcome.Concomitant devices reported as: 2.4/2.7mm ti va lckng x-plate extra small-sterile (part # 04.211.201s, lot # 9414726, quantity 1), 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 22mm (part # 04.211.022s, lot # 9613647, quantity 2), 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 16mm (part # 04.211.016s, lot # lo33257, quantity 1), 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 20mm (part # 04.211.020s, lot # lo97230, quantity 1).This report is for one (1) unknown metallic fragment.It is unknown if the fragments were generated from the screws or the plate.This is report 1 of 1 for (b)(4).

• Type of Device: PLATE, 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: 6180986
• MDR Text Key: 62679673
• Report Number: 2520274-2016-15691
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• 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: ONE (1) 2.4/2.7MM TI VA LCKNG X-PLATE(04.211.201S); ONE (1) 2.7MM TI VA LCKNG SCR 16MM (04.211.016S); ONE (1) 2.7MM TI VA LCKNG SCR 20MM (04.211.020S); TWO (2) 2.7MM TI VA LCKNG SCR 22MM (04.211.022S)