MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT; IMPLANT

Catalog Number UNK_TNE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/28/2014

Event Type  Injury  

Event Description

After hansson pin surgery, cut out was found.Revision surgery was performed.This case was presented at the meeting of (b)(6) society for fracture repair on (b)(6) 2014.It is the first case of two cases.

Manufacturer Narrative

The device will not be returned.Additional information was requested and if received will be provided on a supplemental report.

Manufacturer Narrative

Evaluation summary: the reported incident could not be confirmed, since no further information is available and the device is not returned for evaluation.This case was presented at the meeting of (b)(6) 2014, no further information was available.Due to lack of details in the information provided it is difficult to make any conclusions on what has caused the cut out of the hansson pin.The use of the implant is very well documented in scientific articles and has shown very good results in its intended use.Cut out is likely to be clinical or patient related rather than implant correlated.In the instructions for use, v15014 rev b non active implant elos medical ifu is stated following: ¿in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.[¿] conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ [¿] avascular necrosis.¿ [original statement].Indications for any material, manufacturing or design related problems were not determined in the investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device and x-rays must be available in order to determine the root cause of the complaint event.If any further information is provided, the investigation report will be updated.

Event Description

After hansson pin surgery, cut out was found.Revision surgery was performed.This case was presented at the meeting of (b)(6) 2014.It is the first case of two cases.

• Brand Name: UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4204054
• MDR Text Key: 4978551
• Report Number: 0008031020-2014-00510
• Device Sequence Number: 1
• Product Code: HTY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_TNE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• 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