MAUDE Adverse Event Report: STRYKER GMBH PREDRILLING ASSEMBLY-SHORT APEX Ø 5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5057-5-100
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem 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.".
Additional Manufacturer Narrative
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 or Problem 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.".
Additional Manufacturer Narrative
Correction: please refer to d9/h3, h6 (method, 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 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.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 or Problem 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.".

• Brand Name: PREDRILLING ASSEMBLY-SHORT APEX Ø 5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13388692
• Report Number: 0008031020-2022-00025
• Device Sequence Number: 4659242
• Product Code: LXH
• UDI-Device Identifier: 07613327089653
• UDI-Public: 07613327089653
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2022
• 2 Devices were Involved in the Event: 1 2

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: 5057-5-100
• Device Catalogue Number: 50575100
• Device Lot Number: H37364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 02/03/2022; 04/14/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/02/2022; 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown