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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18321035S
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 10/28/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device evaluated by mfr: hospital policy.
 
Event Description
On (b)(6) 2016, t2ph surgery was performed.After that backout of the most proximal screw was found and removal of the screw was performed.After the screw removal, the reduction position was deviated.The revision surgery was performed on (b)(6) 2016.The date of the first revision is unknown.This pi is related to (b)(4) and mention the second revision.
 
Manufacturer Narrative
[remark: the revision surgery due to screw back-out was already subject of (b)(4); the reported proximal humeral nail of (b)(4) is identical to the nail reported in this case.This pi is related to the 2nd revision surgery where the deviated reduction position was corrected which was detected after removal of the backed-out screw (1st revision).] evaluation revealed both the proximal humeral nail and the (unknown) screw to be the primary products.A physical examination could not be carried out as the reported devices were not returned for examination due to ¿hospital policy¿ according to information received.A review of the device history records of the proximal humeral nail revealed no discrepancies.The item was documented faultless prior to distribution.Thus, we exclude deviations in material and manufacturing.A review of the device history records of the reported screw could not be carried out as the lot code (and the catalogue number) was unknown and not provided.Although requested further information such as x-rays were not provided.However, no malfunction of a product was reported.The issue is about a deviated reduction position which was corrected during a revision surgery after it has been detected ¿one month and a half after the surgery¿ according to information received.A comprehensive examination and investigation was not possible based on the minimal information given and in absence of the nail and screw in question.With available information a deficiency of the reported nail and screw could not be verified.The root cause could not be determined.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no actions in place related to the reported event for the subject product(s).No non-conformity was found.
 
Event Description
On (b)(6) 2016, t2ph surgery was performed.After that backout of the most proximal screw was found and removal of the screw was performed.After the screw removal, the reduction position was deviated.The revision surgery was performed on (b)(6) 2016.The date of the first revision is unknown.This pi is related to (b)(4) and mention the second revision.
 
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Brand Name
PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX. HUM. Ø8 X 150 MM
Type of Device
ROD, 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 Key6126130
MDR Text Key60845968
Report Number0009610622-2016-00585
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K042396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2021
Device Catalogue Number18321035S
Device Lot NumberK03FC1B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
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