MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CUSTOMIZED MAND. RECON PLATE20, FULL; IMPLANT

Model Number	78-31020
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scapula was not designed as the surgeon expected.The surgeon decided to move the surgery date and move forward with a new design.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed according to the documentation along to this case.The handover document was filled out per the surgeon¿s request that the cmrp plating surface should be along the superficial side of the right scapula.But, the planning was performed with the plating surface being along the deep side of the right scapula.The respective vsp case report showed the planning accordingly and had a note: ¿plating along deep scapula surface¿.The planning session for this case was held on 03-may-2022 by a stryker designer, who is trained for an offsite planning session according to vsp planning procedure of 3d systems.The discrepancy explained above occurred in this planning session and was noted during review by 3d systems.The reviewing (3ds) planner reached out on 06-may for clarification via teams message.This message was not noticed by the stryker designer due to the teams chat message being from external, and consequently no answer provided.3d systems proceeded with the assumption that the documentation was incorrect, and the performed planning correct.This assumption was incorrect and noticed by the stryker designer on (b)(6) 2022.Because this was 1 day prior surgery date, the stryker designer immediately informed the surgeon.The surgeon then decided not to use the plate and guides and postponed the surgery.The surgeon met with the designer for a re-planning session on the same day, and a remake case was initiated with the correct design.The affected cmrp plate and all 3d systems products related to this pi were returned to stryker freiburg.Conclusively, the event is related to a manufacturing issue related to the design process and addressed in an nc.Therefore, no further action is required at this time.
Event or Problem Description
It was reported that the scapula was not designed as the surgeon expected.The surgeon decided to move the surgery date and move forward with a new design.

• Brand Name: CUSTOMIZED MAND. RECON PLATE20, FULL
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 15098876
• Report Number: 0008010177-2022-00024
• Device Sequence Number: 5427846
• Product Code: JEY
• UDI-Device Identifier: 07613252599661
• UDI-Public: 07613252599661
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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
• Device Model Number: 78-31020
• Device Catalogue Number: 78-31020
• Device Lot Number: 2205021003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown