MAUDE Adverse Event Report: AESCULAP AG & CO. KG TC MAYO-HEGAR NDL HOLDERHVYSERR185MM; NEEDLE HOLDER

Model Number BM066R

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Facility reports the device broke during surgery and a piece was lost inside the patient.

Manufacturer Narrative

Manufacturing site evaluation: product received with one of the hard metal inlays is broken 2 mm from the tip.Investigation was completed visually, using the digital microscope.This failure is user/maintenance related.The tip of the carbide metal may have broken off due to a needle being picked up and it slipped off the needle holder or by aggressive maintenance methods, the solder area may have dissolved, resulting in the carbide metal being brittle.Corrective / preventive action(s): not applicable.

• Brand Name: TC MAYO-HEGAR NDL HOLDERHVYSERR185MM
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen DE 78 532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5046424
• MDR Text Key: 25060588
• Report Number: 2916714-2015-00751
• Device Sequence Number: 1
• Product Code: HXK
• 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: Followup
• Report Date: 01/13/2016

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: BM066R
• Device Catalogue Number: BM066R
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other