MAUDE Adverse Event Report: AESCULAP AG RONGEUR WAGNERHEAVY PATTERN STR200MM; RONGEURS

Model Number FF818R

Device Problem Component Missing (2306)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).During maintenance after an operation, the customer found that motion of working end was defective and a hole for rivet/pin was seen.However, rivet/pin was missing.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.The pin is broken, but the fragment is not available for investigation.The manufacturing date is not longer comprehensible, the last maintenance of the instrument was carried out in march 2007.Deposits can be found all over the surface, caused by an insufficient reprocessing.The blade of the lower part is damaged, most likely caused by grasping a hard object.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rational: in correlation with the old age of the instrument and the damaged blade, the breakage of the pin was most likely caused by high operating force during application.No capa is necessary.

• Brand Name: RONGEUR WAGNERHEAVY PATTERN STR200MM
• Type of Device: RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7635756
• MDR Text Key: 112453536
• Report Number: 9610612-2018-00239
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF818R
• Device Catalogue Number: FF818R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/06/2018
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other