MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 CRTX SCR LOW PROF HD STPING/SD/22; SCREW, FIXATION, BONE

Model Number	02.206.222
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
Additional Manufacturer Narrative
Reporter is a synthes employee.Manufacturing location: monument.Manufacturing date: october 26, 2014.Part: 02.206,222, 3.5mm crtx screw/low prof hd self-tapping/star drive/22mm lot: 7834885 (non-sterile).Work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿product received from millstone was not the correct (described) part in the package; does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.Visual inspection: an unknown self-tapping screw was received at us customer quality (cq) without the label and was not directly etched with a part / lot number.The part number was identified during the dimensional inspection.There were no issues identified with the returned device.Dimensional inspection: upon dimensional analysis, the part number was identified to be ¿02.206.226¿ as the length of the screw was measured to be 26.43 mm which is within the specification per the drawing.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.3.5 mm cortex screw with low profile head.Investigation conclusion: the complaint condition was confirmed as different product was received in the package.The impacted product was captured as part: 02.206.222, lot: 7834885.However, based on the above dimensions, the part number was identified to be 02.206.226 which belongs to the same ¿3.5mm crtx screw/low prof hd self-tapping/star drive¿ family.Based on the investigation findings, relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 during receipt of product for replenishment inventory, the 3.5mm cortex screws self-tapping low-profile t15 stardrive recess was not the part in the package.There were no patient and surgical involvement.This report is for a 3.5 cortex screw.This is report 1 of 1 for (b)(4).
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.H10 additional narrative: h3, h6: manufacturing location: monument manufacturing date: 26-oct-2014 part number: 02.206,222, 3.5mm crtx screw/low prof hd self-tapping/star drive/22mm lot number: 7834885 (non-sterile) lot quantity: 114 work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿product received from millstone was not the correct (described) part in the package¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.Visual inspection: an unknown self tapping screw was received at us customer quality (cq) without the label and was not directly etched with a part / lot number.The part number was identified during the dimensional inspection.There were no issues identified with the returned device.Dimensional inspection: upon dimensional analysis, the part number was identified to be ¿02.206.226¿ as the length of the screw was measured to be 26.43 mm (calipers: ca215p) which is within the specification.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed - 3.5 mm cortex screw with low profile head complaint confirmed? yes, the device received was incorrect.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed as different product was received in the package.The impacted product was captured as part number: 02.206.222, lot #: 7834885.However based on the above dimensions, the part number was identified to be 02.206.226 which belongs to the same ¿3.5mm crtx screw/low prof hd self-tapping/star drive¿ family.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: 3.5 CRTX SCR LOW PROF HD STPING/SD/22
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11560753
• Report Number: 2939274-2021-01501
• Device Sequence Number: 4497150
• Product Code: HWC
• UDI-Device Identifier: 10886982051004
• UDI-Public: (01)10886982051004
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 02.206.222
• Device Catalogue Number: 02.206.222
• Device Lot Number: 7834885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1