MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	212.103
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
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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 an order of screws were received with empty packages.There was no patient involvement.This report is for 1 3.5mm locking screw slf-tpng w/stardrive(tm) recess 14mm.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: h6: a device history record (dhr) review was conducted: manufacturing location: monument manufacturing date: 22-oct-2020 part number: 212.103, 3.5mm locking screw slf-tpng w/stardrive ¿ recess 14mm lot number: 76p0483 (non-sterile) lot quantity: 232 three pieces were scrapped in cell, mill threads/thread head, due to a robot misload.A five-piece (shortage) quantity variance was recorded, flow inspect/pack.Production order traveler met all inspection acceptance criteria apart from the eight pieces noted.Inspection sheet, mill threads / thread head / flute / final inspection, met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and determined to be conforming.A total of 241 labels were printed; 232 labels were used on product; 1 label was used on the pll and 8 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 ¿empty package received¿ 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.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: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11147602
• Report Number: 2939274-2021-00150
• Device Sequence Number: 19747488
• Product Code: KTT
• UDI-Device Identifier: 10886982151773
• UDI-Public: 10886982151773
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 212.103
• Device Catalogue Number: 212.103
• Device Lot Number: 76P0483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1