MAUDE Adverse Event Report: SYNTHES BETTLACH SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)

Catalog Number 309.068

Device Problem Break (1069)

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

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age & weight not provided for reporting.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that the: part #309.068, lot #l015343.Manufacturing site: (b)(4).Manufacturing date: 25.Aug.2016.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition, remark: lot l015343 has the internal part number 36598.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 a patient initially underwent surgery on (b)(6) 2011 for a slipped capital femoral epiphysis (scfe) of the left hip.The patient was brought back to the operating room on (b)(6) 2017 for the hardware removal of the scfe, 7.3 mm cannulated screw and surgical dislocation of the hip for osteochondroplasty of the femoral neck.During the surgery, it was reported that the bone was dense, thick and had grown over the screw.Therefore, the surgeon had to ream out part of the bone to get to the screw.It was reported that as the surgeon was reaming the bone, a piece of the hollow reamer broke off and remains embedded in the patient.There was a two hour delay in surgery while the surgeon unsuccessfully attempted to remove both the screw and embedded fragment.The void caused by removing the excess bone that covered the screw was filled with a competitor¿s bone graft.It was reported that the patient was stable.Future treatment/surgical plans are unknown at this time.This complaint is for the inability to remove the screw and broken reamer during the revision surgery and resulting two hour delay.Related (b)(4) addresses the revision surgery to remove the cannulated screw.This complaint is for two devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Remove the explant date from the mw (unable to remove screw)., not explanted.Device 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 product development investigation was performed for the subject device: background: the spare reamer tube was not returned for evaluation; thus, a physical inspection could not be performed.An evaluation was performed based on the provide pictures.The device is part of the screw removal set and referenced in the screw removal set technique guide.The reported part (309.068) is a spear reamer tube for the complete reamer (309.065).When assembled, the complete reamer consists of a reamer tube, centering pin, and shaft which allows for the removal of broken screws.The device is intended for removal of 6.5mm and 7.0mm cannulated screws.Device condition: the reported spare reamer tube is shown in the provided images assembled with a reamer shaft from the complete reamer (309.065).The reamer tube shows a roughly spiral break at the distal end such that the entire toothed region has broken off.The broken portion is not shown in the provided images.The fracture extends from just distal of the distal hole to approximately where the lot number begins.No further issues were observed in the provided pictures.No issue with the mating reamer shaft were observed.The complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken and was not returned.Drawing review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.--spare reamer tube for hollow reamer: the design history was found to not impact the complaint condition since the only design revision since the date of manufacture concerns the udi etching.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The device is intended for removal of 6.5mm and 7.0mm cannulated screws the inner diameter of the tube is 7.2mm +0.10/+0.05.However, it was reported that a 7.3mm screw was being removed.It is possible that this use impacted the complaint condition.No definitive root cause was able to be determined as the device was not returned.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: SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6640194
• MDR Text Key: 77539434
• Report Number: 9612488-2017-10266
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982185587
• UDI-Public: (01)10886982185587(10)L015343
• 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,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.068
• Device Lot Number: L015343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR