MAUDE Adverse Event Report: TELEFLEX MEDICAL OLSEN HEGAR 6.5" INSERT; HOLDER,NEEDLE;ORTHOPEDIC

Catalog Number 510445

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: a part of the needle holder broke off and fell into the dog.The piece was retrieved and there was no harm to the patient.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Device history record (dhr) was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 510445 sample of 510445 was received for evaluation.The blade is broken at the pivot point.Rust and dried blood were observed inside the fracture plane.Due to the repeat incidents with this customer - it is likely that this is a site specific issue related to method of use.There are no other complaints for this issue.Sample of 510445 was received for evaluation.The blade is broken at the pivot point.Rust and dried blood were observed inside the fracture plane.Previous complaints were submitted by the same customer.

Event Description

Alleged event: a part of the needle holder broke off and fell into the dog.The piece was retrieved and there was no harm to the patient.The patient's condition was reported as fine.

• Brand Name: OLSEN HEGAR 6.5" INSERT
• Type of Device: HOLDER,NEEDLE;ORTHOPEDIC
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5531835
• MDR Text Key: 41684006
• Report Number: 3011137372-2016-00052
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 510445
• Device Lot Number: H2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• 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: N
• Patient Sequence Number: 1