MAUDE Adverse Event Report: STRYKER GMBH OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 8X8X8MM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES.

Catalog Number EZM080808

Device Problems Failure to Form Staple (2579); Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital reported the following event: "implantation failure.Fragility of the bones preventing the holding of the staples.Obligation to cut one to remove it.

Event Description

The hospital reported the following event: "implantation failure.Fragility of the bones preventing the holding of the staples.Obligation to cut one to remove it.

Manufacturer Narrative

The reported event that osteosynthesis compression staple easyclip 10x10x10mm was alleged of 'implant breakage during surgery' could not be confirmed, since the device did not break but was intentionally cut to be removed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by a poor bone quality.It was reported that surgeon has changed of surgery method because of the poor bone quality of the patient.In order to not damage weak and fragile bone, surgeon decided to use another type of implant.The easyclip is usually inserted in small bones.The compression force is adapted to an average bone quality and due to the "spring feature" of the easyclip it is not or only minimally reduced in the case of bone sintering or bone damage.In patients with of low bone density (advanced osteoporosis) or in the case of poor positioning of the predrilled holes an intraoperative damage of the small bone (s2) might result.In most cases such an event would not any more allow for insertion of an easyclip requiring a change of surgery method (e.G.Fixation with a k-wire).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 8X8X8MM
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7717640
• MDR Text Key: 115109711
• Report Number: 0008031020-2018-00522
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 07613252259442
• UDI-Public: 07613252259442
• Combination Product (y/n): N
• PMA/PMN Number: K070031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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: 01/31/2021
• Device Catalogue Number: EZM080808
• Device Lot Number: 151671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other