MAUDE Adverse Event Report: AESCULAP AP & CO. KG HI-LINE XS FIXED DURAGUARD II; DRILL ATTACHMENT

Model Number GB743R

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Customer reports that duraguards bent easily.In one case, even the dura of a pt was damaged.According to the customer, there was no irreversible harm to pt.Surgery delay was approx.5-10 minutes.The customer states that it is not determinable which product (gb743r or gb742r) with which serial number caused the reported problem.Related to medwatch 2916714-2015-00176.

Manufacturer Narrative

Mfg site eval: eval on-going.

• Brand Name: HI-LINE XS FIXED DURAGUARD II
• Type of Device: DRILL ATTACHMENT
• Manufacturer (Section D): AESCULAP AP & CO. KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG & CO KG; po bpx 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4617982
• MDR Text Key: 16180440
• Report Number: 2916714-2015-00175
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K980686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB743R
• Device Catalogue Number: GB743R
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other