MAUDE Adverse Event Report: STRYKER GMBH OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X15X13MM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES.

Catalog Number EZB101513

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

The reported event that osteosynthesis compression staple easyclip 10x15x13mm was alleged of 'wrong device used' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by an off-label use.It was reported that this easyclip staple was implanted in the femoral area, when this device is dedicated to hand and foot surgeries.Please note that the operative technique (ec-st-1-en_ easyclip optech_2015-7180) and the instruction for use (v15082 rev aa easyclip_memoclip_4fusion) read: "indications the easyclip staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.'' [original statement(s)] therefore this case is classified as user related.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 the device is returned or if any additional information is provided, the investigation will be reassessed.Remains implanted.

Event Description

The surgeon reported : "last tuesday i operated a patient for a thp via dsa.The procedure went smoothly, following the tips from the instructional guide from stryker.Postoperatively the patient developed an n femoralis outage." the customer asks for advise from an expert to avoid this in the future.Update per additional information received (b)(6) 2018 - doctor did a primary hip with a tritanium cup and a exeter femoral stem.He used for the approach the dsa technique , ( direct superior approach ) which is promoted by us since a couple of years.After the operation the patient had a femoralis drop , what is something like a paralysis of the sciatic nerve.There was no revision.

• Brand Name: OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X15X13MM
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7567127
• MDR Text Key: 110028455
• Report Number: 0008031020-2018-00416
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 07613252259367
• UDI-Public: 07613252259367
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K070031
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: EZB101513
• Device Lot Number: L55424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2017
• 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: 71 YR