MAUDE Adverse Event Report: S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG THIN 8IN 3MM RONGEUR, MANUAL

Model Number NL4257-83T

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) on 11oct2016, customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available. Confirmation was also requested from the customer that there was no patient impact associated with reported issue. Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Customer stated via email: customer states that surgeon was using kerrison during an operation. As surgeon was using kerrison, the rivet that holds the screw in the hinge of the kerrison popped out into the patient. The physician immediately noticed the rivet and retrieved it from patient. Customer states that there was no harm to the patient. Customer informed v. Mueller rep on the afternoon of friday, (b)(6). On 11oct2016 additional information: what was the procedure that was being performed? yes incident occurred during case. Did any part the instrument fall into the patient's body and if so how was it retrieved? the screw fell into the wound; surgeon picked it up with forceps. Was there a medical procedure performed to verify if the instrument was in the patient's body, such as an x-ray? not necessary, screw fell out and was immediately retrieved. What was the patient's outcome? no affect. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? sales rep took instrument. Do you have the lot#? listed on the sales rep copy.

Manufacturer Narrative

(b)(4). The sample was provided and an evaluation was performed. The instrument was manufactured in june of 2007. The instrument looks worn and shows repeated repair work performed by unauthorized third party repair companies, such as grinding at the tip as well as on the glider and the main shaft parts. Apparently the screw was not secured appropriately after repair. In addition, the screw returned with the device is not the original screw as per the supplier¿s device master record and device history record. The customer should train its staff that the screws must be checked for tightness after cleaning. There have been no issues identified with the material or manufacturing process. A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: T-COAT MICRO HDL KERR RONG THIN 8IN 3MM
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): S&A MARTIN GMBH; uhlandstrasse 17; rietheim-weilheim 78604 ; GM 78604
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6043215
• MDR Text Key: 57928696
• Report Number: 1423507-2016-00071
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NL4257-83T
• Device Lot Number: XMEG06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/20/2016 Patient Sequence Number: 1