MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11.0MM MEDULLARY REAMER HEAD

Catalog Number 352.110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review was requested.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 the devices were used in surgery for femoral trochanteric fracture on (b)(6) 2018.Without using reaming rod (352.032) beforehand, the surgeon inserted the assembled reaming unit (composed of 352.110 reamer head, 352.040 flexible shaft and 351.150 t-handle in question) into the medullary cavity.Then, the reamer head came off the flexible shaft around the narrowest medullary cavity.The surgeon re-connected the reamer head and the flexible shaft in the medullary cavity, took the entire reaming unit, and completed the surgery with a ten-minute delay.There was no adverse consequence to the patient, who had no fragment left in her body.It was confirmed that the surgeon had not been given a proper guidance on the reaming-device usage.Concomitant parts: 1 qty, p/n 351.150, l/n 2088577; 1 qty, p/n 354-5295, l/n 0000657475; this is report 1 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.

Event Description

Concomitant medical products: 1 qty, synream reaming rod ø2.5 short l950, p/n 352.032, l/n 5942020.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record review was performed for the subject device: part no.: 352.110 , lot no.: 2096934 , manufacturing location: bettlach , release to warehouse date: 04.Jun.2004.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed for the subject device: the manufacturing document of the reamer head were reviewed and no complaint related issues were found, the device was manufactured in the year 2004 according to the specification.A visual inspection was performed and no damage at the reamer head could be observed.In general is the device is in a often used condition, concordant with the age of the device.The function test shows that the also received flexible shafts can be attached and removed from the head as required.Also, we found that the reamer head is locked on the shaft soon the also received reaming rod is in place.No product related issue could be detected.According to the complaint description was the synream system used without reaming rod when the head came off.This is an use error because the reaming head is not secured on the flexible shaft when the reaming rod is not inserted.In this relation we would like to point out the synream surgical technique state: precaution: never ream without using a reaming rod, as it secures the connection between the reamer head and the flexible shaft.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 11.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7324833
• MDR Text Key: 102111159
• Report Number: 8030965-2018-51851
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243743
• UDI-Public: (01)07611819243743(10)2096934
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.110
• Device Lot Number: 2096934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR