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

Catalog Number EZB101513

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/21/2014

Event Type  Injury  

Event Description

Customer reported that smart toe implants were found to be broken 6 weeks post op.Revision surgery is planned after (b)(6), 2014.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: it has been identified that this device is concomitant for this reported failure.If any other information is provided indicating otherwise, the investigation will be reworked.

Event Description

Customer reported that smart toe implants were found to be broken 6 weeks post op.Revision surgery is planned after (b)(6) 2014.

• Brand Name: OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X15X13MM
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES.
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4019317
• MDR Text Key: 19585335
• Report Number: 0008031020-2014-00388
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: EZB101513
• Device Lot Number: F004806PCBM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2013
• 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): Required Intervention