MAUDE Adverse Event Report: SYNTHES SELZACH 9.0MM MEDULLARY REAMER HEAD

Catalog Number 352.090

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is not available for reporting.Udi: (b)(4).Implant and explant daters: device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2017 during an initial total hip replacement surgery, a reamer head was left in the canal.A synthes reamer was used without a ball tip guide wire to ream the canal causing the reamer head came out in the canal, and being retained in the patient.Procedure was successful and patient was in stable condition.A ten (10) minutes delay in surgery was reported.Concomitant devices reported: 5.0 mm flexible reamer shaft (part# 352.040, lot# unknown, quantity# 1).This report is for one (1) 9.0mm medullary reamer head.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 9.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6843684
• MDR Text Key: 84932871
• Report Number: 3000270450-2017-10317
• Device Sequence Number: 1
• Product Code: HTO
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/05/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR