MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7; PIN, FIXATION, SMOOTH

Catalog Number 1910-1273S

Device Problems Device Slipped (1584); Material Deformation (2976)

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

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

It was reported that surgeon performed an achilles repair on patient's ankle (side unknown).As directed by the surgical technique, the surgeon attempted to implant 2 anchors in the calcaneus after calcaneal osteotomy.Upon inspection, sales rep saw that the first anchor was visibly deformed.The slot that the sutures rest in was pinched closed.Rep decided to open the anchor to see if it could be made usable.It could not.The rep reports that he had several anchors available, but had to open a total of 7 anchors to get 2 that were usable.Before closing the patient, surgeon tried to hyperextend to test suture stability.The suture popped out, and the surgeon had to use the 7th anchor.The procedure was completed successfully with a 15-20 minute delay.No additional anesthesia was administered and the rep stresses that this procedure was done according to the published technique.The invalid anchors are available for return.

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6796096
• MDR Text Key: 82891576
• Report Number: 0008010177-2017-00211
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2017

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: 1910-1273S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR