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 Problem Failure to Osseointegrate (1863)

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

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was disposed of.

Event Description

The sonic anchor was being used on an achilles' tendon repair.Six anchors were used.All but one pulled out and did not seem to integrate into bone.The anchors that pulled out were still intact in their original shape.Numerous test runs were done on the machine and hand piece.It all passed inspection and tests.

Manufacturer Narrative

The evaluation revealed all sonic anchors to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The anchors complained were documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.The customer reported that the anchors were used on an achilles' tendon repair.This treatment is listed as indication within the ifu and operative technique.It was reported further that 6 anchors were used, one of them was implanted like specified, an indication that the one anchor was liquefied like specified.Five anchors were implanted but popped out of the drilled holes during wire-strength test with origin shape; indicating that all 5 anchors were completely inserted into the bone holes but did not liquefy.The handpiece and generator were checked and tested several times, indicating that both machines were fully operational.Based on all reported facts two possible reasons would have led to the issue: first: the cancellous bone structure was too weak to give enough resistance; the anchors were pushed forwards through the cancellous structure.Second: it was drilled too deep >6mm.The drill is designed with a stop but with excessive pressure it is possible to break through the corticalis in case of weak bone structure.Both possible reasons are caused by weak bone structures.The ifu and operative technique includes that prior to the surgery the surgeon has to check whether the bone quality is adequate to guarantee a sufficient anchor implantation.Because no manufacturing or material issue was detected the case is attributed to an inaccurate pre-planning by the surgeon.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

The sonic anchor was being used on an achilles' tendon repair.Six anchors were used.All but one pulled out and did not seem to integrate into bone.The anchors that pulled out were still intact in their original shape.Numerous test runs were done on the machine and hand piece.It all passed inspection and tests.

• 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: 5913671
• MDR Text Key: 54277180
• Report Number: 0008010177-2016-00200
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2016

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 Expiration Date: 01/14/2017
• Device Catalogue Number: 1910-1273S
• Device Lot Number: 1000207910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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: 76 YR