MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEUR STR 2MM 155MM; BONE PUNCHES, RONGEURS

Model Number FF832R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2017

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 jaw of the rongeur broke off during the surgical procedure and fell into the operation field.An x-ray was necessary to locate and remove the broken part from the patient.

Manufacturer Narrative

Investigation: the product is not available for investigation.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 user related.Rational: based on the quality standards we exclude a material or manufacturer caused error.It is liable that a mechanical overload situation led to the breakage.No capa in necessary.

• Brand Name: CASPAR RONGEUR STR 2MM 155MM
• Type of Device: BONE PUNCHES, 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 ; 3145515988
• MDR Report Key: 6660358
• MDR Text Key: 78190150
• Report Number: 9610612-2017-00325
• 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,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF832R
• Device Catalogue Number: FF832R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/14/2017
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 06/12/2017
• Supplement Dates FDA Received: 08/31/2017
• 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