MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM; NAIL, FIXATION, BONE

Model Number	212.104
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: ktt.Investigation summary product was not returned.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.A review of the device history record.Device history lot: part number: 212.104, synthes lot number: 44p7687, manufactured by jabil inc-monument.A dhr file from the time of manufacture could not be reviewed because it is not been scanned into tungsten yet.Jde confirmed that the lot was released for sale in apr 2020.A search in mdd nonconformance module confirmed that no non-conformance's occurred during manufacture.Device history batch null, device history review a search in mdd nonconformance module confirmed that no non-conformance's occurred during manufacture.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, the facility took a picture of the implants shipped to show the order confirmation, however, the implants were not inside the bag and the bag was not damaged.The facility placed a standard order and six (6) items were shipped with a quantity of one (1) on each item and none of those items were in the bag.There was no patient nor procedure involvement.This complaint involves three (3) devices.This report is for one (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 16mm.This report is 2 of 3 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10018795
• Report Number: 2939274-2020-02188
• Device Sequence Number: 19575132
• Product Code: JDS
• UDI-Device Identifier: 10886982151780
• UDI-Public: (01)10886982151780
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 212.104
• Device Catalogue Number: 212.104
• Device Lot Number: 44P7687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/01/2020
• Patient Sequence Number: 1