MAUDE Adverse Event Report: SYNTHES GMBH RA2.0MM RAPID RESORBABLE STRAIGHT PLATE 4 HOLES-STERILE; PLATE, BONE

Catalog Number	852.004.01S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned sample found the implant was broken from one end.The broken fragment was not returned for evaluation.The observed condition is likely due to the application of significant force during the implantation process.However, with available information, the complete potential cause can not be established.According to the surgical technique rapidsorb resorbable fixation system the following are mentioned: the implants must never be bent, notched or scratched in their cold, rigid state, as this may result in surface damage or internal load concentrations, providing possible starting points for product failure.Plates may be heated and contoured up to three times.Bending/contouring of plates, meshes and foils must not be repeated more than three times.Do not store the implant(s) in the hot water bath.Additionally, the device was covered in foreign unknown substance.Potential cause for this condition can be traced to maintenance.However, it can not be fully determined.Refer to the device/country specific ifu for information related to cleaning, sterilization, reprocessing instructions, and inspection procedures a dimensional inspection could not be performed due to the damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the rapidsorb-pl 2 str 4ho t1.2 single pack would have contributed to the device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a.Device history product code: 852.004.01s.Lot number: 243l501.Release to warehouse date: 24.Nov.2023.Manufacturing site: werk bio oberdorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during the surgery, the screw broke during insertion.Due to the screw breakage, the plate cannot be used normally, there is no quality problem with the plate itself.It was changed with another one to continue the surgery, and the same problem happened again.All the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.There was no surgical delay.No additional information could be provided.

• Brand Name: RA2.0MM RAPID RESORBABLE STRAIGHT PLATE 4 HOLES-STERILE
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22167807
• Report Number: 8030965-2025-05751
• Device Sequence Number: 9520490
• Product Code: JEY
• UDI-Device Identifier: 10887587064253
• UDI-Public: (01)10887587064253(17)261101(10)243L501
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 852.004.01S
• Device Lot Number: 243L501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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