MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS CUSTOMIZED CCR BLADESOLID TITAINIUM BLUNT; RETRACTOR BLADE

Model Number PN1998

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Customer has reported that the custom ccr blades do not fit ccr retractor.Discovered while patient was on the table.Surgery delayed by 30-40 mins, no patient injury reported.Case was completed using another vendor's cervical retractor system.Item pn1998 (customized ccr blades) - set of blades; sized a through h used with retractor bw849r.

Manufacturer Narrative

Two out of three sets of ccr blades did not fit retractor.Connection stem was found to be out of tolerance.All three sets of blades were found to bend easily under retraction.The blade thickness was not suitable for sustaining proper retraction.Manufacturing of new blades is recommended.

• Brand Name: CUSTOMIZED CCR BLADESOLID TITAINIUM BLUNT
• Type of Device: RETRACTOR BLADE
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 615 lambert pointe drive; hazelwood MO 63042
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, MO 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5269200
• MDR Text Key: 32742724
• Report Number: 3005673311-2015-00184
• Device Sequence Number: 1
• Product Code: GAD
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PN1998
• Device Catalogue Number: PN1998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/02/2015
• Date Manufacturer Received: 07/10/2017
• 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