MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - REAMERS

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/08/2008

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown reamer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: belthur, m.Et al.(2008), bone graft harvest using a new intramedullary system, clinical orthopedics and related research, vol.466, pages 2973-2980 (india).The aim of this study is to report the graft volume removed using the ria system and the union rate of the recipient sites in both the ria and iliac crest bone graft (icbg) harvest groups after bone grafting combined with bmp-2.We also compared the complications and donor site pain after bone graft harvest with the ria system with a control group of patients who underwent anterior icbg harvest.Between january 2006 to december 2007, a total of 41 patients (23 males and 18 females) with an average age at surgery of 44.9 years (range, 15-78 years) had bone graft harvested from the femoral or tibial intramedullary canal using an unknown synthes ream irrigator aspirator (ria).6 patients in the study had icbg harvested during one stage of treatment and bone graft harvested using the ria system during another stage of treatment.The minimum follow-up was 3 months (average, 9.1 months; range, 3-17 months).The following complications were reported as follows: in 2 patients, the capturing system disengaged from the reamer during the reaming process.The system was reattached without losing any of the harvested graft.1 patient had their anterior femoral cortex perforated because of eccentric reaming of the canal.Only partial weight bearing was allowed on the lower limb for 3 months.The patient had persistent pain in the distal anterior thigh for approximately 4 months after the procedure and then the pain resolved.1 patient had a piriformis entry point rather than a greater trochanteric entry point to the femoral canal.A 15-mm reamer head was used to harvest the graft.This resulted in excessive reaming of the femoral neck.The patient underwent prophylactic fixation of the femoral neck to prevent a femoral neck fracture.The average total pain score for the ria group was 7.41 points.The average intermediate pain score for the ria group was 3.51 points.The average chronic pain scores were 0.10 points for the ria group.This is for an unknown synthes reamer irrigator aspirator (ria).This is report 2 of 2 for (b)(4).

• Brand Name: UNK - REAMERS
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8841842
• MDR Text Key: 152662859
• Report Number: 8030965-2019-66655
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention