MAUDE Adverse Event Report: TECOMET, INC. CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C6855

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Inspection of the device found that the device is not working properly and the tip was found to be broken.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: cautions: inspect instrument prior to use to ensure proper function; no loose pins or misalignment, and that the instrument is in good physical condition.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This distributor reported that the c6855, concept linear wide bite punch, straight, device tip broke during an acl reconstruction (with meniscectomy) procedure on (b)(6) 2018.There was no delay or cancellation to the procedure.It is reported that no part of the device fell into the surgical site; therefore, there were no components to retrieve.The reporter has stated that there was no harm to the user or the patient due to this event.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CONCEPT LINEAR WIDE BITE PUNCH, STRAIGHT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TECOMET, INC.; 5307 95th ave.; kenosha WI 53144
• Manufacturer (Section G): TECOMET, INC.; 5307 95th ave.; kenosha WI 53144
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 7654797
• MDR Text Key: 113017485
• Report Number: 1017294-2018-00101
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: BG
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: C6855
• Device Lot Number: 0118C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 72