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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965050S
Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2015
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
 
Event Description
It was reported by the sales rep who was participant at sga surgery. Physician was unable to turn in the locking screw calcanear. The pilot hole with twisted drill 4. 2mm was correct and secure. Dr. Enlarged the hole with twisted drill 4. 5mm. But the screw with complete thread 5mm was unable to turn in, also a second screw from the same type was not able to turn in. Surgery delay 45 minutes. Surgery finished with screw 4mm. Add. 'l info. Received: screw should be placed in lateral calcaneus screw hole. Surgeon did not use this hole. Surgeon placed a 4mm locking screw into the hole instead of the 5mm screw.
 
Manufacturer Narrative
The evaluation revealed the locking screw to be the primary product. No deviations were found during review of the manufacturing and inspection documents (dhr). The screw was documented as faultless prior to distribution. The customer reported that two 5mm locking screws could not be inserted after he pre-drilled the 1st lateral cortex with a 4. 2mm and a 4. 5mm drill. No manufacturing fault was detected regarding the screw, so the operative technique for the t2 ankle arthrodesis system (b)(4) was reviewed. The lateral calcaneus nail hole has an inner thread for a 5mm locking screw. To guarantee a successful mating of screw and nail thread it is necessary to drill a gliding hole through the lateral (1st) cortex with a 5mm drill. It was found that the information to drill a gliding hole with a 5mm drill is missing -> op-tech, page 20 -> "step 5: guided locking of the lateral calcaneal screw". It is only described that the nail hole shall be pre-drilled with a 4. 2mm drill. Therefore the case is attributed to a missing information in the operative technique (design related issue); a new nc was initiated, nc# (b)(4)to address this issue.
 
Event Description
It was reported by the sales rep who was participant at sga surgery. Physician was unable to turn in the locking screw calcanear. The pilot hole with twisted drill 4. 2mm was correct and secure. Dr. Enlarged the hole with twisted drill 4. 5mm. But the screw with complete thread 5mm was unable to turn in, also a second screw from the same type was not able to turn in. Surgery delay 45 minutes. Surgery finished with screw 4mm. Add. Info. Received: screw should be placed in lateral calcaneus screw hole. Surgeon did not use this hole. Surgeon placed a 4mm locking screw into the hole instead of the 5mm screw.
 
Manufacturer Narrative
The evaluation revealed the 5mm locking screws to be the primary products. An investigation and a review of the manufacturing and inspection documents were not possible because neither the 5mm screws, nor the lot codes were available. The root cause could not be determined due to the missing implants. The provided x-rays show that the lateral calcaneus nail hole is filled with a screw. The sales rep stated that the surgeon pre-drilled the lateral calcaneus nail hole with a 4. 2mm and a 4. 5mm drill. It was not possible to insert the 5mm screws; therefore a 4mm screw was inserted instead. Based on the given information following scenarios could have been occurred: both screw threads were damaged intra-operatively prior to insertion. The screws could not be inserted due to mistargeting e. G. Caused by a damaged target device or a damaged drill sleeve. The inner nail thread of the lateral calcaneus hole was damaged intra-operatively. The bone of the patient was dense (e. G. Due to disease). All these scenarios are either user or patient related and are addressed in the ifus for implants and instruments. A more precise evaluation was not possible based on the given information. As a matter of investigation routine the operative technique for the t2 ankle arthrodesis system (b1000044 and lt2aa-ot) was reviewed. As a collateral issue it was found that the information to overdrill the pilot hole with a 5mm drill is described for the talar oblong nail hole, but not explicit mentioned for the lateral calcaneus nail hole. The description of the surgical step to drill the lateral calcaneus nail hole was amended in the t2 aan operative technique, triggered by nc# 1078522. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject product(s). No non-conformity was identified.
 
Event Description
It was reported by the sales rep who was participant at (b)(6) surgery. Physician was unable to turn in the locking screw calanear. The pilot hole with twisted drill 4. 2mm was correct and secure. Dr. Enlarged the hole with twisted drill 4. 5mm. But the screw with complete thread 5mm was unable to turn in, also a second screw from the same type was not able to turn in. Surgery delay 45 minutes. Surgery finished with screw 4mm. Add. Info. Received: screw should be placed in lateral calcaneus screw hole. Surgeon did not use this hole. Surgeon placed a 4mm locking screw into the hole instead of the 5mm screw.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5355315
MDR Text Key35757916
Report Number0009610622-2016-00006
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number18965050S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/08/2016 Patient Sequence Number: 1
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