MAUDE Adverse Event Report: S&A MARTIN GMBH T-COAT MICRO HDL KERR RONG THIN 8IN 1MM RONGEUR, MANUAL

Model Number NL4252-81T

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) on 6/7/2016 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 reported via email that the tip broke off in the patient. Patient impact unknown. On 10jun2016 additional information: what was the procedure that was being performed? acf. Did any part of the instrument fall into the patient's body, and if so how was it retrieved? yes, not retrieved as it went into the neptune suction device. Was there a medical procedure performed to verify if the instrument was in the patient's body, such as an x-ray? c-arm - image was taken to verify broken tip not in patient. What was the patient's outcome? no injury. Was the procedure completed as planned? yes. Can you please send all parts of the instrument for evaluation? no, the kerrison can be returned however the broken piece was suctioned into the neptune canister which is sealed. Do you know the lot #? unsure. Instrument has been sent that had stamped part # nl4252-81t and an etched # in the underside of the handle #844.

Manufacturer Narrative

(b)(4). The sample was provided and an evaluation was performed. The instrument was manufactured in (b)(6) 2011. The hardness was tested and is within specification at 46. 3 hrc (hrc tolerance is 43-48). There is a dent in the material near the fracture line that indicates that the device was subject to excessive stress and wear either during this surgical procedure or prior to this event. Since the broken off tip was not returned, the cause for this incident cannot be determined conclusively. However, review of complaint records with regard to tip fractures shows that these incidents have been due to misuse, such as cutting or forcefully manipulating metal objects, specifically wire. Another cause for this type of failure may be that the cutting edge of the instrument was dull, as is to be expected in view of the age of the device, and that this condition was not detected by the healthcare facility during function testing of the device prior to surgical use. No further analysis possible due to incomplete device returned. 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 1MM
• 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 ; 8473628063
• MDR Report Key: 5726117
• MDR Text Key: 47434481
• Report Number: 1423507-2016-00062
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NL4252-81T
• Device Lot Number: XMEO07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: 06/15/2016 Patient Sequence Number: 1