MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 CLOSED/OPEN DOMINO CONNECTOR 11MM; MPLANTS POSTERIOR STABILISATISW843T

Model Number SW843T

Device Problem Break (1069)

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

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation:evaluation on-going.

Event Description

Country of complaint: (b)(6).On the primary surgery, fixation was done by using two connectors (sw843t) for both sides (left and right each).One month later, two connectors on the left were loosened.A year later, the connectors were completely uncoupled.On the(b)(6) 2016, rod on the other side was broken.No harm to the patient was reported.

Manufacturer Narrative

Investigation: used test and analysis equipment: -keyence vhx 600 d digital microscope.-panasonic dmc tz8 digital camera.We made a visual inspection of both connectors and the enclosed screws.One of the screws shows an incorrect wear pattern, caused by a slipping rod.The other screw shows a right but underdeveloped wear pattern, caused by an improper tightening.Both connectors exhibit strong wear, caused by an improperly applied or tightened rod.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 is most probably usage related.Rational: both connectors exhibit the typical signs of incorrectly applied rods and incorrectly tightened screws.No capa is necessary.

• Brand Name: S4 CLOSED/OPEN DOMINO CONNECTOR 11MM
• Type of Device: MPLANTS POSTERIOR STABILISATISW843T
• 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: 6216580
• MDR Text Key: 63867576
• Report Number: 9610612-2016-00009
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123352
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW843T
• Device Catalogue Number: SW843T
• Device Lot Number: 52104365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/13/2016
• Device Age: 1 YR
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR