MAUDE Adverse Event Report: SYNTHES GMBH 4.5 CANNULATED SCREW PARTIALLY THRD/52; SCREW, FIXATION, BONE

Model Number	214.552
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device history lot: manufacturing location: monument, manufacturing date: 25-oct-2022, part number: 214.552, 4.5mm cannulated screw partially threaded/52mm, lot number: 2720p72 (non-sterile), lot quantity: 94, production order traveler met all inspection acceptance criteria apart.Inspection sheet, turn/wobble broach, inspect gun drill, mill shaft threads& flutes, final inspection, ns073434 rev c met all inspection acceptance criteria.Packaging label log (pll) lppf rev h, lmd rev b was reviewed and determined to be conforming.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.Device history batch null.Device history review: 06-dec-2022: dhr reviewed 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 an unknown date, that incorrect quantities or product missing from inside the manufacturer's box/case and was labeled incorrectly.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) 4.5 cannulated screw partially thrd/52.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5 CANNULATED SCREW PARTIALLY THRD/52
• 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: 15955143
• Report Number: 8030965-2022-10892
• Device Sequence Number: 7334516
• Product Code: HWC
• UDI-Device Identifier: 10886982154224
• UDI-Public: (01)10886982154224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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
• 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: 214.552
• Device Catalogue Number: 214.552
• Device Lot Number: 2720P72
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown