MAUDE Adverse Event Report: AESCULAP AG & CO. KG TC MAYO HEGAR NDL HOLDERHVYSERR205MM; NEEDLE HOLDER

Model Number BM067R

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Tip of tc insert broke during c-section operation.No pt injury.Surgery delay 40-45 mins.Broken tip was retrieved with direct visualization, x-ray used to confirm no fragments remained.The broken piece of the tip will not be returned for evaluation.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the tip of the carbide metal insert of the received device is broken off.The instrument was analyzed with the digital microscope (b)(4) by keyence.Hardness was tested with hardness tester vickers hv 5, ident no.30077.Carbide metal - target:1150 +-50 hv , actual: 1180 hv.Basic material - target: 420 +110 hv , actual: 505 hv.The hardness is according to the specifications.It is assumed that the user tried to grasp a needle with the tips of the needle holder as the needle slipped and caused the breakage; however this is not confirmed.The damage is likely user related.Corrective / preventive action(s) is not required.

• Brand Name: TC MAYO HEGAR NDL HOLDERHVYSERR205MM
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 78532
• Manufacturer (Section G): AESCULAP AG & CO KG; p.o. box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4845224
• MDR Text Key: 5932226
• Report Number: 2916714-2015-00480
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

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: BM067R
• Device Catalogue Number: BM067R
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1