MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FEN.5/310MM; BIPOLAR REUSABLE INSTRUMENTS

Model Number PM438R

Device Problem Material Fragmentation (1261)

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

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation: no product on hand.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records are not possible.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: according to the quality standard a production error and a material defect can be excluded.Without the product we cannot determined the exact cause but through to our basic experience we assume there is the possibility that the ceramic breakage was caused by an improper handling due to a mechanical overload situation.Possibly an excessive force has been applied on the instrument or the possibility of torsion or high leverage with the instrument.No capa necessary.

Event Description

It was reported that there was an intraoperative ceramic break of an instrument.It was reported on (b)(4) 2019 the customer confirmed that before surgery it was noticed the blue ceramic on the maryland forceps was partially missing.The customer is not certain when the breakage occurred.The previous use of the device was on (b)(6) 2019.An x-ray was performed on the patient from the 21st, which revealed there was no indication of the ceramic fragment(s) on the x-ray picture and the physician concluded that breakage happened most likely after the surgery on (b)(6) 2019.No surgery delay during this case.It was reported that the device had been used 6 times prior to this incident.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
• Type of Device: BIPOLAR REUSABLE INSTRUMENTS
• 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: 8348618
• MDR Text Key: 136491013
• Report Number: 9610612-2019-00063
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM438R
• Device Catalogue Number: PM438R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/01/2019
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention