MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES INCL 2 DCP(TM) HOLES; PLATE, FIXATION, BONE

Model Number	02.100.016
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: the investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.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.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) 2022, during an unknown procedure while plating a pubic symphysis, a locking screw would not lock into the plate.The surgeon decided to redirect a 3.5 cortex screw for bicortical fixation.The surgery was completed successfully.There was a surgical delay of five (5) minutes.There were no patient consequences.This report is for one (1) 3.5mm pubic symphysis plate 6 holes incl 2 dcp(tm) holes this is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM PUBIC SYMPHYSIS PLATE 6 HOLES INCL 2 DCP(TM) HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13621215
• Report Number: 2939274-2022-00693
• Device Sequence Number: 12216675
• Product Code: HRS
• UDI-Device Identifier: 10886982028273
• UDI-Public: (01)10886982028273
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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: 02.100.016
• Device Catalogue Number: 02.100.016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 47 KG