MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL S2 Ø9X375 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 17220937S

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The pharmacist at the hospital, reported the following event to the sales rep: "on (b)(6) 2017, a s2 nail was implanted by dr (b)(6).On (b)(6) 2017 - revision of the patient performed by dr (b)(6).By explanting the nail : it was fractured in 2.Event will be reported to (b)(6).".

Manufacturer Narrative

Evaluation revealed the broken nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).Available information revealed that the nail allegedly broke after a period of approx.6 weeks of implantation.In this case it was reported that a relative young male patient had been active, post-operatively.The surgeon¿s post-op recommendations were to authorize partial support with english canes.It was not possible to examine the implant regarding evidences of exceeding weight bearing which would be additional material deformation in the bearing points; usually caused by the patient¿s activity.As no deviation was found in the manufacturing documents a deficiency of the documented nail was not verified.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There were no actions in place related to the reported event for the subject product.No non-conformity was identified.Potential adverse events and potential root causes are / were stated in the labelling.The event was not linked to a deficiency of the devices but was rather linked to patient factors.If additional information is received the investigation will be reopened.

Event Description

The pharmacist at the hospital, reported the following event to the sales rep: "on (b)(6) 2017, a s2 nail was implanted by dr (b)(6).On (b)(6) 2017 - revision of the patient performed by dr (b)(6) by explanting the nail : it was fractured in 2.Event will be reported to (b)(6).".

• Brand Name: TIBIAL NAIL S2 Ø9X375 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7131261
• MDR Text Key: 95319486
• Report Number: 0009610622-2017-00380
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 17220937S
• Device Lot Number: K02C8F2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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: 58 YR
• Patient Weight: 110