MAUDE Adverse Event Report: TELEFLEX MEDICAL KUYPER-MURPHY STERNAL RET MED; INSTRUMENTS SURGICAL CARDIOVAS

Catalog Number 341398

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during use of item 341398, it kept binding up.The handle is rubbing inside and creating shavings.There were no injuries to the patient.

Manufacturer Narrative

(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 341398.(1) sample of 341398 lot: j9 (oct 2019) was received for evaluation.Visual review noted a burr on the superior edge of the moving arm with an embedded metal chip.The embedded chip has scrapped the top side of the rack with a visible wear mark.The embedded chip does not appear to originate from the assembly and may have appeared during cleaning.The device functions as expected.A weight load was placed on the moving arm and cycled through the range of movement with no metal shavings created.I was not able to replicate the reported failure under load.The source of the metal chip could not be determined but does not appear to originate from the returned device.(1) sample of 341398 lot: j9 (oct 2019) was received for evaluation.Visual review noted a burr on the superior edge of the moving arm with an embedded metal chip.The embedded chip has scrapped the top side of the rack with a visible wear mark.The embedded chip does not appear to originate from the assembly and may have appeared during cleaning.A dimensional inspection was not required as part of this investigation.The device functions as expected.A weight load was placed on the moving arm and cycled through the range of movement with no metal shavings created.I was not able to replicate the reported failure under load.No confirmed complaints were received in this range with the same issue.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 341398.The source of the metal chip could not be determined but does not appear to originate from the returned device.

Event Description

It was reported that during use of item: 341398, it kept binding up.The handle is rubbing inside and creating shavings.There were no injuries to the patient.

• Brand Name: KUYPER-MURPHY STERNAL RET MED
• Type of Device: INSTRUMENTS SURGICAL CARDIOVAS
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9763958
• MDR Text Key: 191037459
• Report Number: 3011137372-2020-00068
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 341398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1