MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T10 AO, SELF RETAINING; PLATE, FIXATION, BONE

Catalog Number 703880

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "variax remover driver's teardrop handle and driver shaft couldn't lock.When the doctor turned the driver down, the driver slipped out.Doctor's comment: please be careful not to ship a broken instrument in the future.Sr recovered the instrument.He was able to wear it with the driver's tip facing up, but when he pointed it down, the driver tip certainly fell out.".

Event Description

As reported: "variax remover driver's teardrop handle and driver shaft couldn't lock.When the doctor turned the driver down, the driver slipped out.Doctor's comment: please be careful not to ship a broken instrument in the future.Sr recovered the instrument.He was able to wear it with the driver's tip facing up, but when he pointed it down, the driver tip certainly fell out.".

Manufacturer Narrative

The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screwdriver blade was not found to be damaged.The distal end of the screwdriver blade was also undamaged.The event ¿instrument - assembling / disassembling impaired during implantation¿ could be confirmed.When pointing the assembly down, the screwdriver blade falls down.The part of the elastosil handle that locks the screwdriver blade is too loose and releases the blade when the assembly is oriented down.Without effort, the part moves without even touching it.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿the stryker "instructions for cleaning, sterilization, inspection and maintenance" [.] help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ based on investigation, the root cause was attributed to a user related issue.Ifu advises user to examine devices prior to surgery and repeatedly check that the connection between the instruments is secure.If any further information is provided, the complaint report will be updated.

• Brand Name: SCREWDRIVER BLADE T10 AO, SELF RETAINING
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10450181
• MDR Text Key: 207315911
• Report Number: 0008031020-2020-02188
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K170727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 703880
• Device Lot Number: 1000349496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1