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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CM CONNECTING BOLT - ASIA ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT

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ZIMMER SWITZERLAND MANUFACTURING GMBH CM CONNECTING BOLT - ASIA ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation results were made available. Event description: it was reported that during surgery on (b)(6) 2021, the surgeon tried to connect the cmn femoral nail to the targeting guide with the connecting bolt. However, the connecting bolt could not be connected after multiple attempts and got stuck. The surgeon then used a backup nail with a slightly different ccd angle to complete the surgery. A surgical delay of up to 15 minutes was reported. Harm: s2 - exposure to anesthesia, minor hazardous situation: instrument cannot be used with, or detached from, a mating instrument or mating implant as intended. Review of received data: no medical data relevant to the case has been received. Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested. Images: nine images of the involved devices (cmn femoral nail and connecting bolt) were received of which five of these images show the nail and four show the bolt. Four images of the nail show the area of interest, namely the thread of the nail. Some polishes surfaces on and around the thread as well as signs of abrasion around the circumference of the 13. 5h7 bore hole can be seen. One image of the bolt shows two bolts next to each other. It remains unknown which bolt is the complained product and which one was used to complete the surgery. The lot numbers of both of the bolts are the same (13765813). No apparent conspicuousness on either the thread of the bolts or the bolts in general can be seen, apart from several signs of usage (scratches). On another image the product id of both bolts can be seen (00-2490-003-04). On two further images the lot numbers of each bolt is shown (13765813). Product evaluation: visual examination: only the reported cmn femoral nail was received for investigation. The m11 thread shows polished surfaces. Signs of abrasion can be seen on the circumference of the 13. 5h7 bore hole, in particular below both grooves of the bore hole. There is a thin abrasive line running along the circumference of the bore hole. These mentioned phenomena likely can be attributed to the reported event, whereby it was attempted multiple times to connect the bolt to the nail. Functional test: a functional test was performed with two different m11-6h thread limiting plug gauges (pm071101506h, z8833 and 063. 313. 801-v50-11), which passed. The good side of the gauges can be threaded with the nail review of product documentation: device purpose: all involved devices are intended for treatment. Product compatibility: the product combination was approved by zimmer biomet. Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found. Correspondence with shop floor (dl1789524): a potential correlation of the reported event to a known issue of coaxiality (ie-17143) for the nails can be ruled out, conclusion: it was reported that during surgery on (b)(6) 2021, the surgeon tried to connect the cmn femoral nail to the targeting guide with the connecting bolt. However, the connecting bolt could not be connected after multiple attempts and got stuck. The surgeon then used a backup nail with a slightly different ccd angle to complete the surgery. A surgical delay of up to 15 minutes was reported. The quality records show that all specified characteristics have met the specifications valid at the time of production. Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob). No medical records related to the reported event were received. Images of the nail as well as two involved connection bolts of the same lot number were received. It remains unknown which bolt is the complained product and which one was used to complete the surgery. No apparent conspicuousness on either the thread of the bolts or the bolts in general can be seen, apart from normal signs of usage. However, the evaluation of the condition of the connection bolts is limited to the views and quality of the images that were provided. None of the connection bolts were returned for investigation. Only the cmn femoral nail was returned. The thread shows polished surfaces. Signs of abrasion can be seen on the circumference of the 13. 5h7 bore hole, in particular below both grooves of the bore hole. There is a thin abrasive line running along the circumference of the bore hole. These mentioned phenomena likely can be attributed to the reported event, whereby it was attempted multiple times to connect the bolt to the nail. A functional test was performed with two different thread limiting plug gauges, with both tests passing. Therefore, the reported event cannot be confirmed. Due to neither of the connection bolts being returned for investigation, a thorough investigation of these devices as well as their interaction with the received cmn femoral nail can not be performed. Additionally, both connection bolts were manufactured in 2013. It can be therefore assumed that these devices were used for multiple procedures and possibly show signs of wear or even deformation on the thread, although not clearly seen on the images provided, potentially affecting its functionality and thus contributing to the reported event. However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue. The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed. Zimmer biomet's reference number of this file is (b)(4). The following reports are associated with this event (b)(4).
 
Event Description
It was reported that during surgery a surgeon tried to connect the cmn femoral nail to the targeting guide with the connecting bolt. However, the connecting bolt could not be connected after multiple attempts and got stuck.
 
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Brand NameCM CONNECTING BOLT - ASIA
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13025466
MDR Text Key282392763
Report Number0009613350-2021-00673
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00249000304
Device Lot Number13765813
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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