MAUDE Adverse Event Report: AESCULAP AG LEWIN BONE CLAMP SERR 180MM; BASIC INSTRUMENTS

Model Number MD455

Device Problem Break (1069)

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

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instrument is not available for investigation.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.It appears that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most likely usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.There is the possibility for a usage error due to improper handling or mechanical overload situation.If further investigations are required, the product should be provided for examination.

Event Description

Per sus voluntary event form mw5086909, received by the fda, there was an instrument malfunction.It was reported that there was an issue with the lewin bone clamp.During a knee arthroplasty procedure, the bone clamp was used to attempt to grasp the femoral head.One side of the instrument broke off at that time; next, the handle and piece were retrieved and the parts were matched-up to ensure that nothing remained within the sterile field.There was no patient harm or surgical delay.Further information was not received.

• Brand Name: LEWIN BONE CLAMP SERR 180MM
• Type of Device: BASIC 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8744450
• MDR Text Key: 149784643
• Report Number: 9610612-2019-00440
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019

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: Health Professional
• Device Model Number: MD455
• Device Catalogue Number: MD455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/30/2019
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/28/2019
• 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