MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM; PIN, FIXATION, THREADED

Model Number 5018-5-120

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the following issue: "when inserting in the motor a 5 mm fiche diameter of the hoffman 3 in its own guide (they verified that the guide was the correct one for the 5 mm diameter), after about 10 seconds the surgeon reported an overheating and a blockage of the fiche in the guide, as if a ¿merger¿ has happened.".

Manufacturer Narrative

Correction: please refer to d1, d2a, d2b, d9/h3, h5 and h8 more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A inspection of the received pictures has shown that four article are visible, two pin and two sleeve.By one pin the tip is broken off and missing.The single sleeve shows no signs of malfunction or damage.The other pin and sleeve are plugged-in each other, no malfunction or damage is visible.Based on this we are not able to do any further statement, but as the parts are plugged-in each other complaint is confirmed.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

Event Description

The customer reported the following issue: "when inserting in the motor a 5 mm fiche diameter of the hoffman 3 in its own guide (they verified that the guide was the correct one for the 5 mm diameter), after about 10 seconds the surgeon reported an overheating and a blockage of the fiche in the guide, as if a ¿merger¿ has happened.".

Manufacturer Narrative

Correction: please refer to d9/h3, h6 (method code, results & conclusion codes) the complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received ¿predrilling assembly-short apex ø 5mm¿ and ¿self-drilling half pin apex ø 5mm¿, which are plugged-in each other, with no chance to separate.Furthermore, the instrument shows at proximal end deformation, on the distal end the sharp tip of the sleeve is badly damaged and deformed from use.In addition, the implant shows deformation at the recess side and the tip is badly deformed from use.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a use related issue.If any additional information is provided, the investigation will be reassessed.

Event Description

The customer reported the following issue: "when inserting in the motor a 5 mm fiche diameter of the hoffman 3 in its own guide (they verified that the guide was the correct one for the 5 mm diameter), after about 10 seconds the surgeon reported an overheating and a blockage of the fiche in the guide, as if a ¿merger¿ has happened." (b)(6)/2022 - additional information received from the customer: the patient is fine, he has already been operated for the conversion to definitive synthesis with success, we only had a modest dilation of the operating times.The procedure, albeit with delay, was successfully completed.To overcome the retention of the pin fragment we had to vary the insertion technique (instead of using hole 2 and hole 4 as i usually do i used 1 and 5 leaving the "half hole" with the tip of the pin retained in position 3 obviously pin free).

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13388742
• MDR Text Key: 286775942
• Report Number: 0008031020-2022-00026
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091908
• UDI-Public: 07613327091908
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K001886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5018-5-120
• Device Catalogue Number: 50185120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1