MAUDE Adverse Event Report: AESCULAP AG TC NEEDLE HOLDER X-DEL SERR200MM

Model Number BM026R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Device broke during a hip fracture.An x-ray was performed and found to be negative for retained piece.No patient injury; surgery delay 10-15 minutes.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: one of the hard metal inlays of the received instrument was broken 2 mm from the tip.The solder is partially dissolved.Investigation was completed visually, using digital microscope keyence vhx-600.The breakage is user/maintenance related.The breakage appears to have resulted from a needle slipping off the needle holder.Aggressive maintenance methods can result in dissolving of the solder, causing the carbide metal to become brittle.Corrective/preventive action is not required.

• Brand Name: TC NEEDLE HOLDER X-DEL SERR200MM
• Type of Device: NEEDLE HOLDER
• 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: 5183931
• MDR Text Key: 30219563
• Report Number: 2916714-2015-00989
• 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: Initial,Followup
• Report Date: 01/21/2016

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: No Information
• Device Model Number: BM026R
• Device Catalogue Number: BM026R
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other