MAUDE Adverse Event Report: AESCULAP AG DUROGRIP NEEDLE HOLDER STR.D:5/310MM

Model Number PL407R

Device Problem Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).The metal part which goes into the handle is not closing.There was no patient injury but a 30 minute delay in surgery as there were no others available to use.Additional report submitted at the same time, same facility, same event description.See 2916714-2016-00023.

Manufacturer Narrative

The needle holders are in a used condition.The tips of the locking pin are broken off.The fragments are not available.The instruments were analyzed by microscope.No pores, inclusions or foreign bodies could be found.The device quality and manufacturing history records are not possible.Based on the information available as well as a result of the investigation, root cause of the failure is most probably a material error.The current failure rate is within the risk analysis and therefore acceptable.

• Brand Name: DUROGRIP NEEDLE HOLDER STR.D:5/310MM
• 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: 5368537
• MDR Text Key: 36051446
• Report Number: 2916714-2016-00022
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/08/2016

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: PL407R
• Device Catalogue Number: PL407R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/11/2016
• Device Age: 4 YR
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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