MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/4MM; MANDIBLE DISTRACTION DEVICES

Model Number	04.315.744.01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent a revision procedure to re-position the cmf-distractor for bone screw loosening in the posterior footplate.During the revision procedure the original implants which consist of one (1) 1.0mm mesh foot b-type, one (1) 1.0mm mesh foot c-type, 15mm bc distractor, one (1) 30mm removal extension arms and seven (7) 1.3mm titanium raised head screws were all explanted and a new implant was implanted and needed to be repositioned due to the challenging bony anatomy of the patient.No x-rays were involved in this procedure.The patient is a neonate and as the patient was undergoing distraction post operatively the surgeon believed he could get better results by adjusting the position on the distractor.The procedure was successfully completed without any surgical delay.Patient status is unknown.Concomitant device reported: 1.0mm mesh foot b-type for cmf distractor (part # 04.315.202, lot # unknown, quantity 1), 1.0mm mesh foot c-type for cmf distractor (part # 04.315.203, lot # unknown, quantity 1), bc distractor body end act.(part # 04.315.023, lot # unknown, quantity 1), removable extension arm-flex (part # 04.315.125, lot # unknown, quantity 1).This complaint involves seven devices (7) devices.This report is for one (1) 1.3mm ti raised head screw self-drilling/plusdrive®/ 4mm.This report is 1 of 7 for (b)(4).
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.B5: additional information.H3, h6: 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.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
Additional information: there was no malfunction with the device, the device was taken out and placed in a new position where the patient had better bone stock.

• Brand Name: 1.3MM TI RAISED HEAD SCREW SELF-DRILLING/PLUSDRIVE®/4MM
• Common Device Name: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10033500
• Report Number: 2939274-2020-02280
• Device Sequence Number: 2956301
• Product Code: MQN
• UDI-Device Identifier: 10887587072180
• UDI-Public: (01)10887587072180
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.315.744.01
• Device Catalogue Number: 04.315.744.01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/19/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR; 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR; 1.3MM TI RAISD HD SCRW SLF-DRLNG/PLUSDR®/4MM; BC DISTRCTOR BODY END ACT. 15MM, CMF DISTR; REMOVABLE EXT ARM-FLEX 30MM, CMF DISTRACTOR; 1.0MM MESH FOOT B-TYPE FOR CMF DISTRACTOR; 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR; 1.3MM TI RAISD HD SCRW SLF-DRLNG/PLUSDR®/4MM; BC DISTRCTOR BODY END ACT. 15MM, CMF DISTR; REMOVABLE EXT ARM-FLEX 30MM, CMF DISTRACTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 DA
• Patient Weight: 5