MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 PERCUTANEOUS CEMENT APPLICAT.CANNULA

Model Number SR148SU

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

Reported device is not marketed in the u.S.; however, this device was used with devices that are registered in the u.S.And may have contributed to the reported incident.

Event Description

Country of complaint: (b)(6).It was reported that during an augmentation surgery, the surgeon found the sleeves to be too short.Connection to the clamping sheath was not possible.Surgery was successfully completed using a different procedure (macs); no patient injury was reported.Two additional products reportedly involved in this incident are being reported on med watch report numbers: 3005673311-2016-00147.3005673311-2016-00149.

Manufacturer Narrative

Investigation: no product at hand.Batch history review: because there is neither an product nor a lot / batch number at hand, a batch history review is not possible conclusion and root cause: the problem is most probably user related.Rational: because this is the only complaint with such an error pattern, it is assumed, that the problem is most probably user related.Corrective action: no capa is necessary.

• Brand Name: S4 PERCUTANEOUS CEMENT APPLICAT.CANNULA
• Type of Device: CANNULA
• 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: 5912082
• MDR Text Key: 54209612
• Report Number: 3005673311-2016-00148
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NARRATIVE
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SR148SU
• Device Catalogue Number: SR148SU
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/25/2016
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other