MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS TSPACE PEEK/XP INSERTION INSTRUMENT; SPINAL INSERTION INSTRUMENT

Model Number SN305R

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Instrument locked when engaging and disengaging.When uncoupling from the implanted cage, the cage was ripped out.The instrument had to be decoupled with power.Surgical delay of 30 minutes.

Manufacturer Narrative

Investigation used test and analysis-equipment: microscope "keyence- vhx 600 d," digital-camera "panasonic dmc tz8.First we made a visual inspection of both instruments.Apart from the little impact on the tip of instrument "a", we found no damages.Next we made a function test with both instruments.The locking and release function of both instruments worked well and without any abnormalities, 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 for the problem is most probably user related.Rational: both instruments are working well and without any functionally deviation.

• Brand Name: TSPACE PEEK/XP INSERTION INSTRUMENT
• Type of Device: SPINAL INSERTION INSTRUMENT
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 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: 5376793
• MDR Text Key: 36287233
• Report Number: 3005673311-2016-00018
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Initial,Followup
• Report Date: 06/21/2017

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: No Information
• Device Model Number: SN305R
• Device Catalogue Number: SN305R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/07/2016
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other