MAUDE Adverse Event Report: SYNTHES BETTLACH 13.0MM MEDULLARY REAMER HEAD

Catalog Number 352.130

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4) lot number unknown.Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter address is not provided for reporting.(b)(6).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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the surgery performed on (b)(6) 2017, the 13.0 mm medullary reamer head had come apart from the flexible reamer shaft while reaming the canal.Surgeon was unable to reattach the reamer head as it was lodged within the intramedullary canal.As a result surgeon had to leave the reamer head within the canal of the patient.The surgeon confirmed that they did not use the product in the correct manner, so this is what caused the failure.It is unknown if the surgery was delayed due to the reported event.The patient was not affected.The surgeon confirmed that the issue would not cause a problem.The reamer head did not break off, they removed the reaming rod, and then placed the reamer down the canal, and this is when it came off the reamer shaft.Concomitant devices reported: flexible reamer shaft (quantity 1), reaming rod (quantity 1).This report is for one (1) 13.0 mm medullary reamer head.This is report 1 of 1 for (b)(4).

• Brand Name: 13.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6731452
• MDR Text Key: 80642107
• Report Number: 9612488-2017-10313
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• 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
• Treatment: REAMER SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QTY 1; REAMING ROD (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention