MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING Ø3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 705004

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)

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

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported that he recently performed a contoured anterolateral distal tibial plate to a pilon fracture and that measuring directly after drill, the screws in the distal part of the tibia were in excess of a centimetre too long.These all had to be removed and replaced after using the direct measuring guide.The customer further reported that there are two sets of screw in guides and drills which are approximately 15 millimetres different in length and both marked with orange bands.The customer is concerned that with two different drills and drill guides it is possible for them to be mixed up and in this instance has wasted a number of screws, in addition to risking neurovascular structures by the implantation of screws that are too long.

• Brand Name: DRILL SLEEVE, LOCKING Ø3.1MM, SHORT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 8081172
• MDR Text Key: 127565966
• Report Number: 0008031020-2018-00983
• Device Sequence Number: 0
• Product Code: LXH
• Reporter Country Code: GB
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 705004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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