MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 14MM; SCREW, FIXATION, BONE

Model Number	204.814
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the photo was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the packaging of the 3.5mm cortex screw self-tapping 14mm is not clearly visible due to poor quality of the image.Pictures do not provide enough evidence to confirm the reported condition.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.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 3.5mm cortex screw self-tapping 14mm.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: manufacturing location: monument manufacturing date: (b)(6) 2021 part number: 204.814, 3.5mm cortex screw self-tapping 14mm lot number: 116p080 (non-sterile) lot quantity: 238 production order traveler met all inspection acceptance criteria.There was a two piece undercount reported at op #60, flow inspect/pack.Inspection sheet, final inspection ns070756 rev a met all inspection acceptance criteria.Packaging label log (pll) lppf rev e, lmd rev a was reviewed and determined to be conforming.A total of 241 labels were printed.238 labels were placed on product; 1 label was placed on the pll and 2 labels were destroyed.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿product missing from its packaging¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: (b)(6) 2023: dhr reviewed by: mschoenfeld this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.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 on (b)(6) 2023, a product missing from its packaging upon receipt.They wanted to report this complaint and would need a reshipment of this product, this report is for one (1) 3.5mm cortex screw self-tapping 14mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16837628
• Report Number: 8030965-2023-05433
• Device Sequence Number: 6889473
• Product Code: HWC
• UDI-Device Identifier: 10886982146250
• UDI-Public: (01)10886982146250
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• 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 Model Number: 204.814
• Device Catalogue Number: 204.814
• Device Lot Number: 116P080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown