MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PLH LEFT PROXIMAL PLATE 4 HOLE; IMPLANT

Catalog Number UNK_SEL

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the sales representative that a patient with plh plates and 4.0 locking screws is scheduled for revision on (b)(6) 2017, because, the locking screws have been popping out, reversing out, and unscrewing.Physician requested information regarding whether or not these events have been reported as he has never had this happen with a patient before.Company rep clarified that "per surgeon the screws started reversing out about 2 weeks after surgery.

Manufacturer Narrative

The reported event that 2 locking screws backed out from a proximal lateral humerus plate could be confirmed thanks to the provided x-rays.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The most likely reason why the locking screws backed out is that the surgeon did not tighten them correctly using the torque limiter.Our operative technique states that final tightening of the locking screw is always to be performed by hand using the 2.5nm torque limiter ((b)(4)) in combination with a screwdriver bit t15 ((b)(4)) and the t-handle ((b)(4)).Performing final tightening by hand ensures that these screws are tightened to a torque of 2.5nm.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported by the sales representative that a patient with plh plates and 4.0 locking screws is scheduled for revision on (b)(6) 2017, because, the locking screws have been popping out, reversing out, and unscrewing.Physician requested information regarding whether or not these events have been reported as he has never had this happen with a patient before.Company rep clarified that "per surgeon the screws started reversing out about 2 weeks after surgery.

• Brand Name: UNKNOWN PLH LEFT PROXIMAL PLATE 4 HOLE
• Type of Device: IMPLANT
• 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: 6534950
• MDR Text Key: 74112287
• Report Number: 0008031020-2017-00273
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 52 YR