MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49331020

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

Patient Problem No Code Available (3191)

Event Date 10/13/2014

Event Type  Injury  

Event Description

It was reported that patient had left tibia surgery.After surgery, patient went home and apex adaptor cracked.Patient returned to clinic to have new adaptor put in.After second adaptor was put in, it was realized that base was sheared off.Patient will have second adaptor revised on (b)(6) 2014.This complaint is referencing the second adaptor.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the reported event that hoffmann lrf apex pin adaptor had a stress crack corrosion issue after surgery can be confirmed.The root cause of this breakage has been identified as a design issue (material not resistant enough to corrosion).This problem has been identified during nc and is addressed by a capa.A new material will be implemented as soon as validated by bml and r&d.As this breakage is due to a design issue, a credit note will be done.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.If any further information is provided, the investigation report will be updated.

Event Description

It was reported that patient had left tibia surgery.After surgery, patient went home and apex adaptor cracked.Patient returned to clinic to have new adaptor put in.After second adaptor was put in, it was realized that base was sheared off.Patient will have second adaptor revised on (b)(6) 2014.This complaint is referencing the second adaptor.

• Brand Name: APEX PIN ADAPTOR - SHORT HOFFMANN LRF FOR PIN Ø3-4-5-6MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 4229583
• MDR Text Key: 4975328
• Report Number: 0008031020-2014-00536
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113327
• 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: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 49331020
• Device Lot Number: R25479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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: 33 YR