MAUDE Adverse Event Report: AESCULAP AG & CO. KG DISTRACTION DRILL GUIDE F/FF901&FF903

Model Number FF907R

Device Problem Break (1069)

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

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

Eval: eval on-going.

Event Description

Country of complaint: (b)(6).Drill guide broke during use.Operation delay greater than 15 minutes.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx 5000 digital camera and a panasonic dmc tz8 digital camera.We investigated the instrument and broken part optically.We did not find any signs of excessive force.Conclusion and root cause: the root cause of the problem is most probably design related.Rational: there are no hints of a damage or similar.Without further knowledge about the circumstances we assume that the design of the gap between the parts are not optimized for soldering.A design change for this issue is planned in october 2017.No capa is necessary.

• Brand Name: DISTRACTION DRILL GUIDE F/FF901&FF903
• Type of Device: DRILL GUIDE
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 78532 ; GM 78532
• 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: 5011585
• MDR Text Key: 24122992
• Report Number: 3005673311-2015-00095
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF907R
• Device Catalogue Number: FF907R
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other