MAUDE Adverse Event Report: AESCULAP AG KERRISON THIN-FT 130DG-UP 3MM; BONE PUNCH

Model Number FF773R

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint received via facility medwatch: no triage sequence number identified.Screw came off from a kerrison rongeur.The screw was recovered before any procedure was performed and closure of the wound site.Form indicates that the device can be picked up, as the end user does not send products back to manufacturers.Arrangements were made to pick up the device however, the end user would not release product for investigation.

Manufacturer Narrative

No product at hand.Conclusion and root cause: no product available and therefore an analysis is not possible.No capa is necessary.

• Brand Name: KERRISON THIN-FT 130DG-UP 3MM
• Type of Device: BONE PUNCH
• 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: 5743424
• MDR Text Key: 47996324
• Report Number: 2916714-2016-00494
• Device Sequence Number: 1
• Product Code: LRY
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF773R
• Device Catalogue Number: FF773R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2016
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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