MAUDE Adverse Event Report: SYNTHES MONUMENT 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM FOR IM NAILS; SCREW,FIXATION,BONE

Catalog Number 04.005.540

Device Problem Sticking (1597)

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

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information is not available for reporting.(b)(4).Device malfunctioned intra-operatively and unknown if it was implanted / explanted.Device is not expected to be returned for manufacturer review/investigation because it was discarded by facility.(b)(6).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 they were delayed in removing a locking screw.Surgery was prolonged for 30 minutes and completed successfully.No fragments were generated.No other medical intervention was required.The locking screw was not broken.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Original implant date is unknown.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

Further it was clarified that it was a planned implant removal surgery, which was performed on (b)(6) 2017.During the hardware removal surgery surgeon tried to explant the locking screw; however, he could not explant it well.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM FOR IM NAILS
• 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: 6742513
• MDR Text Key: 81136862
• Report Number: 1719045-2017-10695
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000089
• 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,Followup
• Report Date: 06/29/2017

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: 04.005.540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/28/2017
• 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