MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 16MM; CRANIAL PLATE CLAMP

Model Number FF491T

Device Problem Device Operational Issue (2914)

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

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).Product did not affix properly during surgery.Surgery was delayed longer than 15 minutes.

Manufacturer Narrative

Investigation: used test and analysis equipment; keyence-vhx 600 d microscope; (b)(4) digital camera.We made a visual inspection of all parts.At the pin of the lower disc we noticed damaged fixation rims, wear marks on the shaft and a skewed cutting edge.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause of the problem is most probably user related.Rational: the damages on the pin of the lower disk are a result of an incorrectly applied upper disk.The upper disk was driven down to the bottom of the pin/lower disk (wear marks at the shaft).Then the upper disc rocked back-caused by high mechanical tension-and damaged the fixation rims.Further, the fixation pin was not cut correctly (skewed).No capa is necessary.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 16MM
• Type of Device: CRANIAL PLATE CLAMP
• 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: 5385358
• MDR Text Key: 36650212
• Report Number: 2916714-2016-00050
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 52168403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/20/2016
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other