MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM CANNULATED SCREW LONG THREAD 10MM; SCREW, FIXATION, BONE

Catalog Number	211.810
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date, the customer reported that product packaging was dirty and empty.Customer received all items except for one of the 10 mm 2.4 cannulated screw.Per receiving, there was nothing in this package.It came open and the package was dirty.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H.11.Additional narrative: added: a3a.Corrected: g1 (manufacturing site name).H3, h6: photo investigation: the product was not returned to j&j medtech orthopaedics.However, photos were provided for review.The photo investigation revealed only one side of the package, and it was observed a unknow substance on the label.Additionally, it can be observed that the package was open.The complaint information has been reviewed, and it was determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of the device after it was released for distribution.However, a delivery service issue (dsi) is indicated and addressed internally within a local quality management system.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the 2.4mm cannulated screw long thread 10mm would have contributed to the complained device issue.Based on the investigation findings, a deliver service issue (dsi) is indicated and addressed internally within a local quality management system.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.Device history review (dhr): part # 211.810.Lot # 7427570.Manufacturing site: werk selzach logistik.Release to warehouse date: 31.March.2015.Supplier: (b)(4).Expiration date: n/a.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.

• Brand Name: 2.4MM CANNULATED SCREW LONG THREAD 10MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2425 ; SZ 2425
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22714293
• Report Number: 8030965-2025-08004
• Device Sequence Number: 21115340
• Product Code: HWC
• UDI-Device Identifier: 10886982151483
• UDI-Public: (01)10886982151483(10)7427570
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 211.810
• Device Lot Number: 7427570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2015
• 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