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 Patient Involvement (2645)

Event Date 06/02/2014

Event Type  malfunction  

Manufacturer Narrative

With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from (b)(4).The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on august 1, 2014.  stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.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.This lot of parts for both part numbers was reworked, restoring parts to their intended configuration of left hand and right hand.

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.This lot of parts for both part numbers was reworked, restoring parts to their intended configuration of left hand and right hand.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5321295
• MDR Text Key: 34918063
• Report Number: 0008031020-2015-00624
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/03/2014

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: 06/03/2014
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• 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