MAUDE Adverse Event Report: TELEFLEX MEDICAL KUYPER-MURPHY STERNAL RET MED; STERNAL RETRACTOR

Catalog Number 341398

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample has been returned however the investigation report has not been submitted at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: metal shavings from the retractor were found inside the patient.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).(1) sample of (b)(6) was received for evaluation.Visual examination did not detect any metal shavings.The device was disassembled to find damage to the pinion.Galling was observed on the internal surfaces.The galling is the result of initial damage caused during assembly.The rack may have impacted/damaged the sliding surfaces of the pinion during assembly.Alternately- debris may have been captured in the joint prior to use.Either would result in the galling of the joint.The customer has had this happen twice now; this is a site specific failure.The device still functions as intended when tested under heavy loading.No metal shavings were observed during testing.It is also possible that the metal shavings were introduced during sterilization and may have originated from another device in the load.No functional issues found.

Event Description

Alleged event: metal shavings from the retractor were found inside the patient.The patient's condition was reported as fine.

• Brand Name: KUYPER-MURPHY STERNAL RET MED
• Type of Device: STERNAL RETRACTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5097301
• MDR Text Key: 26760279
• Report Number: 1044475-2015-00369
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/28/2015

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: 341398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1