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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH SPARE REAMER TUBE FOR HOLLOW REAMER (309.450)

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SYNTHES BETTLACH SPARE REAMER TUBE FOR HOLLOW REAMER (309.450) Back to Search Results
Catalog Number 309.480
Device Problems Break; Tip
Event Date 12/14/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(6) the patient¿s exact weight was reported as (b)(6). Device is an instrument and is not implanted or explanted. Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Device history record review: manufacturing location: (b)(4) - manufacturing date: march 12, 2008. No non-conformance reports 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. 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.

 
Event Description

It was reported that a reamer tip broke while performing a dynamic hip screw (dhs) revision surgery on (b)(6) 2015. During the procedure, the intact plate and all of the screw fragments were removed. As the surgeon was removing the broken screws, the tip of the hollow reamer broke off. The reamer fragments were easily retrieved using forceps; no additional intervention or unanticipated x-rays were required. After the reamer broke, the surgeon utilized other readily available devices to remove the screw fragments and complete the procedure without delay this report will address the intraoperative events only. The reason for the revision will be captured in and reported under (b)(4). This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

A product development investigation was performed for the subject device (spare reamer tube for hollow reamer, part number 309. 450, lot 325754). The subject device was received with the complaint condition ¿tip broken intraoperatively. ¿ the device was received with a missing portion at the distal tip. The break extends from the distal tip to the 3. 5mm hole. The three remaining cutting teeth each show significant scraping. The fracture sites were examined and no material voids or irregularities were identified. The balance is in working condition and shows wear consistent with use. Thus, 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. Further evaluation shows that this device is a component of the hollow reamer (309. 450) and also available individually for replacement. This hollow reamer is intended for use in the removal of broken 4. 0mm, 4. 5mm, 4. 9mm, and 5. 0mm screws. If the break is located it the shaft, the device is also appropriate for 6. 5mm, 7. 0mm, and 7. 3mm cannulated screws. This information is provided per the screw removal set technique guide. A review of the current design drawing / manufactured revision was performed. The design history was found to not impact the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. A root cause cannot be definitively determined as the circumstances at the time of the break and the maintenance of the device overs it¿s approximately 6. 5 year lifespan are unknown. However, the condition is consistent with having been subjected to extensive forces outside of recommended usage, such as off-axis use and/or impact with the distal tip. Thus, it is most probable that the complaint condition is a result of the method of use/maintenance over the devices 6. 5 year lifespan. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameSPARE REAMER TUBE FOR HOLLOW REAMER (309.450)
Type of DeviceREAMER
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
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5341649
Report Number9612488-2016-10001
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number309.480
Device LOT Number2325754
OTHER Device ID Number(01)10886982185754(10)2325754
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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