MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX FULL THREAD 3.5MM / L28MM; PLATE, FIXATION, BONE

Catalog Number 614828S

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

The sales rep was informed that a patient was undergoing distal humeral plating when it was noted that the plate pulled loose and the screws were still in the bone.It has been confirmed that this event did not occur during the second revision, but after it.The patient had a plating, it was revised once (b)(4), it was revised a second time (b)(4) and then some time post-operatively, the patient fell again.It was discovered that the distal screws had pulled through the plate.The proximal screws remained in the correct position.The rep confirmed that during the surgery there had been no issue with hard bone reported and that the surgery was completed as expected.It was further confirmed that the correct device has been selected to drive the screws through the plate and they had been inserted at an angle of 15 degrees as per standard protocol.It was decided that the patient would not have further surgery to replace the screws and would have external support (pop or collar and cuff) whilst the bone healed.Device was not return.

Event Description

The sales rep was informed that a patient was undergoing distal humeral plating when it was noted that the plate pulled loose and the screws were still in the bone.It has been confirmed that this event did not occur during the second revision, but after it.The patient had a plating, it was revised once (b)(4), it was revised a second time (b)(4) and then some time post-operatively, the patient fell again.It was discovered that the distal screws had pulled through the plate.The proximal screws remained in the correct position.The rep confirmed that during the surgery there had been no issue with hard bone reported and that the surgery was completed as expected.It was further confirmed that the correct device has been selected to drive the screws through the plate and they had been inserted at an angle of 15 degrees as per standard protocol.It was decided that the patient would not have further surgery to replace the screws and would have external support (pop or collar and cuff) whilst the bone healed.

• Brand Name: BONE SCREW VARIAX FULL THREAD 3.5MM / L28MM
• Type of Device: PLATE, FIXATION, BONE
• 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: 6491184
• MDR Text Key: 72777678
• Report Number: 0008031020-2017-00234
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540597441
• UDI-Public: (01)04546540597441(17)210831(10)V37406
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: H101056
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 614828S
• Device Lot Number: V37406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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