MAUDE Adverse Event Report: AESCULAP AG REILL TENDON STRIPPER #3 D6MM 400MM; SPECIAL PRODUCTS FOR HAND / FOOT SU

Model Number FO930R

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).The surgeon used a open stripper, but it proved difficult to use and the results were inconclusive.

• Brand Name: REILL TENDON STRIPPER #3 D6MM 400MM
• Type of Device: SPECIAL PRODUCTS FOR HAND / FOOT SU
• 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: 5391779
• MDR Text Key: 37612315
• Report Number: 2916714-2016-00049
• Device Sequence Number: 1
• Product Code: HRT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 01/26/2016

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: Health Professional
• Device Model Number: FO930R
• Device Catalogue Number: FO930R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/20/2016
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/26/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other