MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X34MM TL11.5MM; SCREW, FIXATION, BONE

Model Number	604634
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that cannulated screw, partially threaded asnis iii ø4.0x34mm tl11.5mm was alleged of ¿implant - breakage intra-operative¿ could be confirmed, since the product was returned and was found to be broken.The device inspection revealed the following: the product was returned and is indeed broken (approx.Head) in two pieces.Only the proximal part was returned, further threaded part of the screw is missing (remain implanted in patient as per additional information).The breakage surface shows signs of over-torque since the screw broke in a spiral manner.Furthermore, the analysis of the breakage surface shows that the surface is brittle which indicates the application of high forces.The surface of the head has scratches and dents.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu clearly states that ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.' the implant extraction set states that ¿to avoid damaging the screw, make sure the screwdriver is in line with the screw axis and fully inserted.Never use a worn or damaged screwdriver to remove screws.It is recommended that the solid screwdriver be used for screw removal.Strong bone formation around the implant is possible in the pediatric cases using partially threaded screws.This may lead to difficult implant removal with an increased risk of screw head breakage or stripping of screw hexagonal head.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by too much torque being applied to the screw, while being inserted/extracted from the bone.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer informed to sales rep that f&a operation to young male patient.Two screws failed, one was bend and the other one was snap off before it was completely in its place.Surgical delay was approximately 15 minutes.Customer changed the screws.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X34MM TL11.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10099011
• Report Number: 0008031020-2020-01531
• Device Sequence Number: 3321262
• Product Code: HWC
• UDI-Device Identifier: 04546540089694
• UDI-Public: 04546540089694
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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 Model Number: 604634
• Device Catalogue Number: 604634
• Device Lot Number: J38810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1