MAUDE Adverse Event Report: ANDOVER HEALTHCARE INC; HIP PACK

Catalog Number DYNJ56516A

Device Problems Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the a surgeon cancelled a case after a patient was already under anesthesia due to unrolling coflex wrap and finding an unknown bug in the coflex wrap.This coflex wrap is manufactured by another company as stated.The coflex wrap was unrolled prior to the start of a total hip revision.According to the facility, the patient was prepped for surgery and the operating room staff were draping the patient's leg at the time the bug was discovered.The procedure was cancelled and the patient was taken to the recovery room.The patient reportedly recovered without incident.The patient involved in the incident was required to return to have the total hip revision completed.No injury was reported, however the patient was required to undergo anesthesia for a second time to complete this procedure.No additional information is available.A sample is available and was returned for evaluation.The customer reported issue of a bug in the coflex wrap was confirmed and the initial manufacturer was notified of the event.Due to the reported incident and subsequent need for intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a bug was found while unrolling a coflex wrap before the start of a procedure.

• Type of Device: HIP PACK
• Manufacturer (Section D): ANDOVER HEALTHCARE INC; 9 fanaras dr.; salisbury MA 01952
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7242126
• MDR Text Key: 99071810
• Report Number: 1423395-2018-00003
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ56516A
• Device Lot Number: 17YM1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other