MAUDE Adverse Event Report: AESCULAP AG & CO. KG VARIOUS NEEDLEHOLDERS AND ONE FORCEP; NEEDLE HOLDERS, HXK / HTD

Device Problem Material Integrity Problem (2978)

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

Event Date 05/20/2015

Event Type  malfunction  

Event Description

During an orthopedic procedure on (b)(6) 2015, it was noticed that a set of instruments were extremely stained / rusted.There were concerns of sterility and the complete set up was taken down which delayed the surgical procedure by 60 to 90 minutes.No patient injury.Items to be returned: bm066r x 1 : tc mayo-hegar ndl holderhvyserr185mm, bm019r x 2 : tc crile-wood ndl hldrstd serr 200mm, bm016r x 1 : tc crile-wood ndl hldrstrserr 145mm, bm012r x 1 : tc halsey needle holder serr 130mm, bh111r x 2 : halsted-mosquito forceps del cvd125mm.

Manufacturer Narrative

Manufacturing site evaluation: evaluation on going.

Manufacturer Narrative

(b)(4).Devices received for evaluation include: bm066r x 1 manufacturing code -7573p; manufacture date is 2005.Heavy rust colored staining at the distal tip.Shows signs of prior repair.Bm019r x 2: manufacturing code -at0al; manufacture date is 2008.Heavy rust colored staining at the distal tip.Shows signs of prior repair.Manufacturing code -g5098; manufacture date is 2014.Moderate rust colored staining at the distal tip.No signs of prior repair (tape marks).Bm016r x 1 manufacturing code - g5547; manufacture date is 2014.Moderate rust colored staining at the distal tip.No signs of prior repair (tape marks).Bm012r x 1 manufacturing code - g53k6; manufacture date is 2014.Heavy rust colored staining at the distal tip.No signs of prior repair (tape marks).Bh111r x 2: manufacturing code -ewipd; manufacture date is 2012.Moderate rust colored staining in the box lock.No signs of prior repair (tape marks).Manufacturing code -gvuex; manufacture date is 2014.Heavy rust colored staining in the box locl.No signs of prior repair (tape marks).Evaluation of the devices indicates no improper repair or material or manufacturing defects present.Staining can be attributed to improper care and handling due to inadequate water quality and / or cross contamination of metals.No corrective / preventive action is required.

• Brand Name: VARIOUS NEEDLEHOLDERS AND ONE FORCEP
• Type of Device: NEEDLE HOLDERS, HXK / HTD
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4890780
• MDR Text Key: 6073136
• Report Number: 2916714-2015-00545
• Device Sequence Number: 1
• Product Code: HXK
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other