MAUDE Adverse Event Report: STRYKER GMBH CALCANEAL COMPRESSION SCREW, LEFT A3 NAIL M10 X 10MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 9330033

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The device is not available to stryker.

Event Description

Left/right compression screws were labeled (laser etched) incorrectly.The left screws fit into right nails and the right screws fit into left nails.Compression screws for lot 1331001 for part numbers 933-0033 and 933-0034 were confirmed to be assembled incorrectly.

Event Description

Left/right compression screws were labeled (laser etched) incorrectly.The left screws fit into right nails and the right screws fit into left nails.Compression screws for lot 1331001 for part numbers 933-0033 and 933-0034 were confirmed to be assembled incorrectly.

• Brand Name: CALCANEAL COMPRESSION SCREW, LEFT A3 NAIL M10 X 10MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY 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: 5320111
• MDR Text Key: 34757096
• Report Number: 0008031020-2015-00626
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130147
• 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: 07/10/2014

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: 9330033
• Device Lot Number: 1331001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• 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