MAUDE Adverse Event Report: SYNTHES SELZACH 10.5MM MEDULLARY REAMER HEAD

Catalog Number 352.105

Device Problem Break (1069)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 05/07/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: (b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 the 10.5mm medullary reamer head broke into approximately three pieces during a tfn-advanced proximal femoral nailing system (tfna) procedure on (b)(6) 2017.The surgeon pushed the reamer head down the first proximal one-third of the canal before he started reaming.When he started reaming, the reaming head twisted and broke.There were additional x-rays and medical intervention required to retrieve all the pieces, which caused a 45 to 60 minute surgical delay.The surgeon then used an 8.5mm front cutting reamer, then an 11mm reamer, and finally an 11.5mm reamer to successfully complete the surgery.A nail, helical blade, and one distal locking screw were implanted with satisfactory patient outcome.There is 1 device in this complaint.Concomitant devices reported: reaming rod (part number unknown, lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).

• Brand Name: 10.5MM 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: 6598215
• MDR Text Key: 76190921
• Report Number: 3000270450-2017-10185
• 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: 05/07/2017

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: 352.105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2017
• Initial Date FDA Received: 05/30/2017
• 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: REAMING ROD - PART & LOT # UNK, QTY. 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR