MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3; SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS

Catalog Number	SRPIP3
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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.".

• Brand Name: PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3
• Common Device Name: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8898405
• Report Number: 0008031020-2019-01052
• Device Sequence Number: 11445902
• Product Code: MPK
• UDI-Device Identifier: 00886385020334
• UDI-Public: 00886385020334
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: H980002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SRPIP3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1