MAUDE Adverse Event Report: CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK UTERINE CLAMP ANG 300MM

Model Number MB184R

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

It has been reported that the jaw of a uterine clamp broke.It has been reported that there was unknown surgical delay and unknown intervention.

Manufacturer Narrative

Investigation of the returned device indicated breakage at the area of the box hole; where the device is at its thinnest.All specifications (material and measurements) were valid at the time of production, no additional complaints have been received related to this item number.No material or manufacturing defects found.The breakage of the device is likely related to overloading or incorrect handling during use/processing.

• Brand Name: UTERINE CLAMP ANG 300MM
• Type of Device: CLAMP
• Manufacturer (Section D): CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK; 15 daimlerstr.; wurmlingen 78573 ; GM 78573
• Manufacturer (Section G): CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK; 15 daimlerstr.; wurmlingen 78573 ; GM 78573
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5828140
• MDR Text Key: 51356814
• Report Number: 2916714-2016-00641
• Device Sequence Number: 1
• Product Code: HGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MB184R
• Device Catalogue Number: MB184R
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/28/2016
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other