MAUDE Adverse Event Report: SYNTHES SELZACH 8.5MM MEDULLARY REAMER HEAD

Catalog Number 352.085

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient weight was not provided by reporter.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Extra incision made through the patellar tendon to retrieve the fragments and unanticipated x-rays to ensure all fragments were retrieved.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 while using suprapatellar instruments and long flexible reamers for reaming the tibial canal during a left tibial nailing procedure, an 8.5mm medullary reamer head broke off inside of the canal.The surgeon took out the flexible reamer shaft (part of the broken reamer head was attached to it), then used a pituitary instrument to grab the two remaining reamer head pieces.There was a reported one to two hour surgical delay.An extra incision was made through the patellar tendon to retrieve the fragments.Additional x-rays were taken to verify that all fragments were retrieved and it was confirmed that nothing was left behind.The procedure was completed without further incident.This report is 1 of 1 for (b)(4).

• Brand Name: 8.5MM 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5250093
• MDR Text Key: 32121395
• Report Number: 3000270450-2015-10237
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.085
• Device Lot Number: 2153897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2005
• 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: 20 YR