MAUDE Adverse Event Report: SYNTHES HAGENDORF DHS® TRIPLE REAMER-COMPLETE

Catalog Number 338.13

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.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 a dynamic hip system triple reamer coupling nut came loose during an open reduction internal fixation (orif) procedure of the proximal femur performed on (b)(6) 2015.When excessive pressure was applied to the drill, the nut came loose causing the reamer to pass through the femoral head.There was a reported surgical delay of fifteen (15) minutes.The procedure was successfully completed without further incident.The patient's post-operative condition was reportedly stable.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Device was used for treatment, not diagnosis.Device history record (dhr) reviews were performed for the three components of part number 338.13 which included 338.11, lot number 1044 and 338.12, lot number 1047.Component 338.10 was also returned but the lot number could not be clearly identified (manufacturing facility ¿ unknown, mfg date¿unknown), therefore, a dhr review could not be completed for the component.The results of the device history record review are as follows: 338.12/lot # 1047.Manufacturing site: (b)(4).Manufacturing date: 06.May 1997.Dhr not available as device is older than 18 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to the filing and archiving of specification document which was in place until august 2014.338.11/lot # 1044, manufacturing site: (b)(4), manufacturing date: 02.Oct.1997.Dhr not available as device is older than 18 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to the archiving of specification document which was in place until august 2014.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The complainant part was received as three (3) components with information as listed below: 338.10 (lot unknown) - 8.0mm drill bit for dhs/dcs triple reamer, 338.11 (lot 1044) - dhs® reaming head-standard, 338.12 (lot 1047) - knurled nut f/dhs & dcs triple reamers.Product investigation summary: the returned device was examined and was found to function as intended.When the locking nut was fully tightened, the reaming head maintained position as intended.It is likely that the complaint condition is the result of not fully tightening the nut prior to use.The dynamic hip system (dhs) triple reamer (338.13) is utilized to simultaneously drill for the lag screw, ream for the plate barrel, and countersink for the plate/barrel junction during dhs/dcs procedures.The appropriate reaming head is assembled with the dhs triple reamer 8.0mm drill bit (338.10) and the locking nut is tightened per the assembly instructions in the system technique guide.The relevant drawings for the returned instrument were reviewed: assembly, dhs reaming head, and nut.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.No device history record review was able to be completed due to the age of the triple reamer (which was manufactured in 1998).During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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

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: DHS® TRIPLE REAMER-COMPLETE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5348491
• MDR Text Key: 35211238
• Report Number: 2520274-2016-10078
• 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,Followup,Followup,Followup,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/21/2016; 02/08/2016; 02/11/2016; 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/1997
• 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 Age: 50 YR