MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG VARIAX HAND 1.7/2.3 LOCK IMPL MODULE S.L.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 29-17231

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/08/2015

Event Type  malfunction  

Event Description

It was reported that a 24mm mark for 2.3mm bone screw of case is wrong.It has two 26 mm marks.

Manufacturer Narrative

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

Manufacturer Narrative

The reported incident that variax hand 1.7/2.3 lock impl module s.L.Was alleged of issue s-111 (wrong size labeled) could be confirmed.Based on investigation, the root cause was attributed to a supplier related issue the tray shows a discrepancy in the numbers of the 2.3 mm screws.There are two (2) marks for 26 mm and none of 24mm.This most likely happened in the suppliers assembly process.The tray looks correct with no other visual effect.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.

Event Description

It was reported that a 24mm mark for 2.3mm bone screw of case is wrong.It has two 26 mm marks.

• Brand Name: VARIAX HAND 1.7/2.3 LOCK IMPL MODULE S.L.
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4892988
• MDR Text Key: 6828968
• Report Number: 0008031020-2015-00274
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: 29-17231
• Device Lot Number: 1000165119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other