MAUDE Adverse Event Report: STRYKER GMBH SAFETY CLIP (BONE TRANSPORT STRUT) 14 X 12 X 5MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49330401

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event that safety clip (bone transport strut) 14 x 12 x 5mm was alleged of 'component loosened' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.However, a nc and a capa have been raised to address a manufacturing deviation.The nonconformance of the component safety clip can lead to the unlocking of the strut's quick release mechanism.As the hoffmann lrf bone transport system cannot be used without the safety clip, product field actions and a global hold were initiated for safety reason.Therefore, a credit note will be provided.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device not available.

Event Description

Sales rep spoke with dr and he said that the patient came back to clinic last week and was missing 2 of 4 of the clips on the struts.He said this time it was only the 2 posterior struts.The quick locking mechanism was still locked this time so the frames integrity was still intact.

• Brand Name: SAFETY CLIP (BONE TRANSPORT STRUT) 14 X 12 X 5MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6561956
• MDR Text Key: 75152370
• Report Number: 0008031020-2017-00295
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 49330401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/11/2017
• 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): Other