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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
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STRYKER GMBH PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS Back to Search Results
Catalog Number SRPIP3
Device Problem Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
The customer reported that a stryker sbi loan kit arrived at the hospital missing an implant.The patient had already been anaesthetized before the surgeon realized.Once he realized, the surgeon attempted to obtain an implant from (another site) in order to run the case.This was not possible.The patient was kept under anesthetic for 1.5 hours and then the case was abandoned.
 
Event Description
The customer reported that a stryker sbi loan kit arrived at the hospital missing an implant.The patient had already been anaesthetized before the surgeon realized.Once he realized, the surgeon attempted to obtain an implant from (another site) in order to run the case.This was not possible.The patient was kept under anesthetic for 1.5 hours and then the case was abandoned.
 
Manufacturer Narrative
The reported event could be confirmed.This a customer service complaint.Based on investigation, the root cause was attributed to be shipment related.The failure was caused by human error.Upon deeper investigation it is believed that due to the unusual situation of southampton general being placed on an order shipment stop, the loan kit was moved to ship out the following day and the notification subsequently missed.A human error was made resulting in the notification not being sent.Appropriate training has been provided to the teams involved.However, an inspection of the kit should be performed before the surgery in order to avoid such incident (a surgical delay of one hour and half) as mentioned in the cleaning and sterilization guide: "inspection before preparing for sterilization, all medical devices should be inspected.Generally un-magnified visual inspection under good light conditions is sufficient.All parts of the devices should be checked for visible soil and/ or corrosion.Particular attention should be paid to: soil ¿traps¿ such as mating surfaces, hinges, shafts of flexible reamers.Recessed features (holes, cannulations).Features where soil may be pressed into contact with the device, e.G.Drill flutes adjacent to the cutting tip, sides of teeth on broaches and rasps.Cutting edges should be checked for sharpness and damage.Functional checks should be performed where possible: mating devices should be checked for proper assembly.Medical devices with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required).Rotating instruments (e.G.Multiple use drill bits, reamers) should be checked for straightness (this can be achieved by simply rolling the instrument on a flat surface).¿flexible¿ instruments, e.G.Im reamers, should be checked for damage to the spiral element.".
 
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Brand Name
PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3
Type of Device
SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8898405
MDR Text Key161694624
Report Number0008031020-2019-01052
Device Sequence Number1
Product Code MPK
UDI-Device Identifier00886385020334
UDI-Public00886385020334
Combination Product (y/n)N
PMA/PMN Number
H980002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSRPIP3
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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