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 Problems Detachment Of Device Component (1104); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sales rep reported that safety clips have fallen off of his hlrf bone transport frames, in some cases leading to the unlocking of the struts' quick release mechanism.Sales rep verbally clarified that there was only one instance of this event and only one patient.Sales rep verbally reported that the frame was used for bone lengthening.The revision surgery occurred to fix issues with frame.Approximately 6-8 weeks after initial frame put on, clips fell off and struts unlocked; frame stopped lengthening and bone began to heal prior to achieving desired length.Patient was revised to make another osteotomy; locked the original struts and added new clips.

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 manufacturing nc has been raised to address a manufacturing deviation.Therefore, in term of goodwill, 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.

Event Description

Sales rep reported that safety clips have fallen off of his hlrf bone transport frames, in some cases leading to the unlocking of the struts' quick release mechanism.Sales rep verbally clarified that there was only one instance of this event and only one patient.Sales rep verbally reported that the frame was used for bone lengthening.The revision surgery occurred to fix issues with frame.Approximately 6-8 weeks after initial frame put on, clips fell off and struts unlocked; frame stopped lengthening and bone began to heal prior to achieving desired length.Patient was revised to make another osteotomy; locked the original struts and added new clips.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6461539
• MDR Text Key: 71825835
• Report Number: 0008031020-2017-00197
• 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,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 04/11/2017
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73