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

Model Number PL407R

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a mechanism of the needle holder broke during surgery.During an unknown procedure, when the suture was placed, an internal mechanism of the durogrip needle holder broke.This issue created a surgical delay of 30 minutes.Additional details have been requested but not yet provided.

• Brand Name: DUROGRIP NEEDLE HOLDER STR.D:5/310MM
• Type of Device: INSTRUMENTS
• 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: 8187224
• MDR Text Key: 131126822
• Report Number: 9610612-2018-00597
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL407R
• Device Catalogue Number: PL407R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/12/2018
• Device Age: 10 MO
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2018
• 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