MAUDE Adverse Event Report: SYNTHES SELZACH 11.5MM MEDULLARY REAMER HEAD

Catalog Number 352.115

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age and weight is not available for reporting.On (b)(6) 2017 - the device was left in patient as non-implant grade during initial procedure, therefore there is no implant/explant date, however it was removed on (b)(6) 2014.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Dhr was requested.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 the patient underwent a revision of a left femur fracture with lateral entry nail and screws on (b)(6) 2014 due to an infection and non-union.The corrective surgery was performed to repair the non-union of the fracture, clean out the medullary shaft, remove all hardware, clean out two (2) pus pockets and remove the reamer head from the patient's leg.The following hardware was removed; one (1) unknown 11 mm lateral entry nail and four (4) unknown 5.0 mm locking screws.In addition, the following-non-implant grade device was removed; one (1) 11.5 mm medullary reamer head.The patient was revised to unknown hardware.No known surgical delay or patient harm occurred during this procedure.The patient was initially implanted with the hardware (nail and screws) on (b)(6) 2014.During that procedure one (1) 11.5 mm medullary reamer head dislodged and exited the femur into the medial soft tissues (captured in (b)(4)).An attempt to retrieve the reamer head was unsuccessful.Within two (2) weeks, the patient had signs of infection appearing around the operative site and went to a different hospital and surgeon to have cultures taken from his wound.He was told he developed (b)(6) infection in his left leg.At this time he was advised he need a revision surgery which occurred on (b)(6) 2014).On (b)(6) 2015, the patient had a second corrective surgery due to non-union to remove unknown hardware placed during the (b)(6) 2014 revision.It is unknown who is the manufacturer of the devices.The patient now lives with an altered gait, feels daily pain in his left leg, utilizes a cane to walk and has psychological issues in which he experienced a an anxiety attack.His current physician projects that he will require nine (9) to twelve (12) more months of treatment and rehabilitation for his left leg.This complaint involves three (3) devices.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

A customer quality evaluation was performed via picture for the subject device (11.5mm medullary reamer head, part number 352.115, lot number 17856).A physical product was not returned for investigation.A picture of an 11.5mm medullary reamer head (352.115, lot 17856, mfg 08-oct-2007) was provided.The single picture received confirms the part and lot number but does not provide enough detail to confirm the complaint conditions of ¿does not fit with other parts¿ and ¿infection¿ therefore a root cause cannot be determined with the provided information.The overall balance of the device appears to be in good condition with minimal signs of damage.A visual inspection via pictures, drawing review, and device history record review was performed as part of the investigation.The complaint is unconfirmed.Product drawings were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned implant¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the complaint history and risk assessment has been performed for and was found to adequately address the complaint condition.A root cause could not be determined with the provided information.A device history record review was performed for the subject device lot number 17856.Manufacturing location: (b)(4).Date of manufacture: 08.Oct.2007.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.Remark: wrong documents were in the internal archive, correct documents had to be requested from the supplier's archive, which took extra time.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.

• Brand Name: 11.5MM 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: 6802202
• MDR Text Key: 82982864
• Report Number: 3000270450-2017-10293
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194237
• UDI-Public: (01)10886982194237(10)17856
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 352.115
• Device Lot Number: 17856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention