MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 3X12MM160MM

Model Number FF533R

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the rongeur device broke and the part could not be removed from the patient.

• Brand Name: CASPAR RONGEURSTRSERR 3X12MM160MM
• 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: 6675357
• MDR Text Key: 78673267
• Report Number: 9610612-2017-00346
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF533R
• Device Catalogue Number: FF533R
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/27/2017
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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