MAUDE Adverse Event Report: SYNTHES GMBH APPLICATOR KNOB; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 03.812.004

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part 03.812.004, lot 9877536, manufacturing site: (b)(4).Release to warehouse date: may 31, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.A product investigation was completed: the visual inspection of these returned two applicator knobs has shown that the upper notch which connected the oracle slide hammer has some heavy hammer blows visible.The articles are in a desolate condition.A functional test cannot be performed of the detected damage.It was not possible to attach the returned oracle slide hammer at the applicator knob.Therefore, the holding function is not working per design as intended.The relevant features are damaged in a manner which prevents accurate measurement of the features.The damages are clearly caused post manufacturing.The manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.The received condition agree with the complaint description and the complaint therefore is confirmed.The investigation has shown that these returned two applicator knobs has shown that the upper notch which connected the oracle slide hammer has some heavy hammer blows visible.The articles are in a desolate condition.These indications led us assume that the device encountered unintended forces, such as a mechanical overload during surgery, which finally caused the post manufacturing damages.This failure is typically consistent with inadequate handling of the device in combination with high excessive force application.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a procedure, the applicator did not slide over the hammer.There was a surgical delay of five (5) minutes.The surgery was completed successfully.There was no patient consequence.Concomitant devices reported: oracle slide hammer (part number 03.809.972, lot 9820365, quantity 1).This report involves one (1) t-pal spacer applicator knob.This is report 2 of 2 for (b)(4).

• Brand Name: APPLICATOR KNOB
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10889314
• MDR Text Key: 217946184
• Report Number: 8030965-2020-09150
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414624
• UDI-Public: (01)07611819414624
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.004
• Device Lot Number: 9877536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ORACLE SLIDE HAMMER